FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

January 13, 1999
99-02

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
PR* Ironman Chocolate Chip Cookie Dough Nutritional Supplement Bars. Recall #F-112-9.

CODE
a) (ON LABEL) 2104698209 (ON SHIPPING BOX) 21046 98209 MFG07/98 b) (ON LABEL) 2104698211 (ON SHIPPING BOX) 21046 98211 MFG07/98

MANUFACTURER
M.L.O. Products, Inc., Fairfield, California.

RECALLED BY
P. R. Nutrition, Inc., San Diego, California, by press release on or about November 18, 1998, and by letter on November 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Canada.

QUANTITY
Approximately 2592 cases totaling 31,104 boxes consisting of 31,104 bars were distributed.

REASON
Product contains undeclared peanut butter.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Frozen Bars: a) Haagen-Dazs Raspberry & Vanilla Frozen Yogurt Bar (Vanilla Frozen Yogurt Bar coated with Raspberry Sorbet) in packages of 1 bar (2.43 fluid ounces), 3 bars (7.29 fluid ounces), and 10 bars (24.3 fluid ounces); b) Haagen-Dazs Chocolate Sorbet Bar in packages of 3 bars (7.29 fluid ounces) and 10 bars (24.3 fluid ounces); c) Haagen-Dazs Chocolate & Vanilla Frozen Yogurt Bar (Vanilla Frozen Yogurt Bar coated with Chocolate Sorbet) in packages of 3 bars (7.29 fluid ounces). Recall #F-114/116-9.

CODE
Use-by dates of 13 APR 99 to 30 OCT 99, above PLT #34-2015, on the end flaps of the product boxes.

MANUFACTURER
Haagen Dazs Company, Woodbridge, New Jersey.

RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by telephone and letter on November 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Brazil, Canada.

QUANTITY
187,632 cases were distributed. There are 8-12 retail-size packages or cartons of single bars per case.

REASON
Products may be contaminated with calcium chloride.

________
PRODUCT
Dark Chocolate Coating under the label of Coronet or Coronet Passover, in 10 pound blocks, used for further processing. Recall #F-117-9.

CODE
All lot produced prior to September 28, 1998.

MANUFACTURER
Blommer Chocolate Company, East Greenville, Pennsylvania.

RECALLED BY
Manufacturer, by telephone beginning on October 15, 1998, followed by faxed letter on October 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, Pennsylvania, Tennessee, Ohio, Massachusetts, New Jersey, Canada.

QUANTITY
Undetermined.

REASON
Product contains undeclared dairy ingredients.

________
PRODUCT
Coconut Cream Pies, 9 inch size, net weight 33 ounces, in aluminum pans. Recall #F-118-9.

CODE
Pull Dates: "December 16, 1998", and/or "December 17, 1998", baked on 12/13/98 and 12/14/98.

MANUFACTURER
K&B Acquisition, Inc., doing business as Mehaffies Pies, Dayton, Ohio.

RECALLED BY
Manufacturer, by visit on December 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
16 pies were distributed.

REASON
Product contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Icy Springs Drinking Water, bottled in 1-gallon plastic bottles, labeled as bottled by Hilldale Dairy. Recall #F-119-9.

CODE
All codes up to and including JAN 08.

MANUFACTURER
Swiss Valley Farms, Dubuque, Iowa.

RECALLED BY
Manufacturer, by telephone on October 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa, Minnesota, Wisconsin, Illinois.

QUANTITY
74,219 bottles were distributed.

REASON
Product was unfit for food due to off-odor and off-taste.

________
PRODUCT
Kroger Old Fashioned Oats, packed in 18 ounce canisters. Recall #F-122-9.

CODE
"Sell by AUG 14 99 HV" and "Sell by Aug 14 99 HW".

MANUFACTURER
Kenlake Foods, Murray, Kentucky.

RECALLED BY
The Kroger Company, Cincinnati, Ohio, by electronic mail on December 22, 1998. Firm-initiated recall complete.

DISTRIBUTION Alabama, Arkansas, Georgia, Indiana, Illinois, Kansas, Louisiana, Missouri, Mississippi, Ohio, Kentucky, West Virginia, Michigan, North Carolina, South Carolina, Texas, Virginia, Tennessee.

QUANTITY
1,679 cases were distributed.

REASON
Product is contaminated with storage insects.

________
PRODUCT
Chef Bowl brand Ginger in Water, packed in 13 jars, 24 jars per case, Product of Taiwan. Recall #F-123-9.

CODE
None.

MANUFACTURER
Undetermined.

RECALLED BY
Summit Import Corporation, New York, New York, by letter on April 8, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, New Jersey, North Carolina, Florida, Maryland, Massachusetts, Pennsylvania.

QUANTITY
Undetermined.

REASON
Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
UDL brand Sucralfate Suspension, 1 g/10 ml, 10 ml unit dose cups. NDC #51079-846-11. Recall #D-057-9.

CODE
Lot numbers: 710032, 710033, 710034, 710052, 711001 & 711002.

MANUFACTURER
Hoechst Marion Roussel (HMR), Kansas City, Missouri (responsible firm).

RECALLED BY
UDL Laboratories, Largo, Florida (repacker), by letter on December 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
9,684 cases were distributed.

REASON
Bottle defects and/or glass fragments in the bulk drug.

________
PRODUCT
Liquid Oxygen, USP in cryogenic vessels, used for respiratory therapy. Recall #D-060-9.

CODE
lot numbers: 300B805, 335B808, 335B804, 315B805, 328B808, 337B808, 335B805, 337B801, 328B804, 335B802, 335B810, 802C809, 812C802, 814C801, 329B804, 337B803, 335B809, 328B806, 328B807, 337B807, 809C805, 813C801, 337B804, 289B808, 274B801, 321B801, 323B805, 314C801, 327B808, 308B804, 323C803, 244B808, 300B804, 301B803, 328B805, 317B801, 802C805, 813C809, 814C809, 337B804, 329B803, 337B807, 335B802, 335B806, 328B801, 314B802, 306B804, 323C802, 808C812, 808C813, 317B801, 809C808, 329B802, 802C814, 328B810, 328B802. Expiration dates: 9/2/99 - 12/7/99.

MANUFACTURER
Airweld, Inc., Farmingdale, New York (Bulk liquid oxygen supplier).

RECALLED BY
Homecare Concepts, Inc., Farmingdale, New York, by visit and by letter on or about December 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
69 vessels were distributed.

REASON
Failure to perform finished product assays.

________
PRODUCT
Diethylpropion Hydrochloride Controlled-Release Tablets 75 mg, in bulk. The bulk tablets were repacked by Vintage Pharmaceuticals, Inc., Charlotte, NC under two brand names as follows: Vintage Diethylpropion HCl Tablets 75 mg, 250 tablets per bottle, NDC 0254-2689-33 Qualitest Diethylpropion HCl Tablets 75 mg, 250 tablets per bottle, NDC 0603-3290-24, manufactured for Qualitest Products, Inc. Huntsville. Recall #D-061-9.

CODE
S Lots 980151 and 980237 of the bulk product; and lots 099048A, B, and C and 010068A and B of the bottled products.

MANUFACTURER
3M Pharmaceuticals Inc., Northridge, California.

RECALLED BY
3M Pharmaceuticals, St. Paul, Minnesota, by letter on December 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Lot 980151 - 1.039 million tablets; Lot 980237 - 1.043 million tablets were distributed.

REASON
Product contains higher than normal levels of residual benzene.

________
PRODUCT
Triple Antibiotic Plus Ointment (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5mg, Polymyxin B Sulfate 10,000 units, Lidocaine 40 mg), 1 oz tube, topical ointment, under the following labels: G&W, Smith's, Hy-top, Medic, F&M, and May's. Recall #D-067-9.

CODE
Lot #6151-1 EXP 6/98.

MANUFACTURER
G&W Laboratories, Inc., South Plainfield, New Jersey.

RECALLED BY
Manufacturer, by letter dated May 4, 1998, followed by telephone. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
42,840 1-ounce tubes were distributed; firm estimated that less than 5% of product remained on market at time of recall initiation.

REASON
Subpotent (18 Month Stability) Bacitracin Zinc-58% declared Neomycin Sulfate-87% declared Polymyxin B Sulfate-84% declared.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Nitroglycerin Extended Release (ER) Capsules, 2.5 mg, oral solid dosage form product packaged in 100 count bottles and in bulk cartons, Rx drug used in the prevention and treatment of angina pectoris associated with coronary artery disease. Brand name: "NITRO-TIME", distributed under the following labels: Time-Cap Labs Schein Pharmaceutical, United Research Laboratories (URL), Qualitest Pharmaceuticals. Recall #D-021-9.

CODE

 
Lot J051H, EXP date: 8/2000.
Time-Caps:  NDC 49483-221-10
Schein   :  NDC 0364-0174-01              
URL      :  NDC 0677-0485-01
Qualitest:  NDC 0603-4782-21

MANUFACTURER
Time-Cap Labs, Inc., Farmingdale, New York.

RECALLED BY
Manufacturer, by letter dated October 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Florida, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New York, Pennsylvania.

QUANTITY
15,918 100-count bottles and 353,940 bulk capsules were distributed.

REASON
Product fails content uniformity testing.

________
PRODUCT
Fluorescein Sodium Injection, 250 mg/mL,in 2 ml sterile single dose vials, sold under the label Angiofluor 25% Injection (NDC 59449-010-02) and AK-Fluor 25% Injection label (NDC 17478-250-20, Rx indicated for ophthalmic angiography and angioscopy in diagnostic examination of the fundus, in evaluation of the iris vasculature; to differentiate between diagnosis of malignant and non-malignant tumors; and in determination of circulation time and adequacy of the circulation. Recall #D-043-9.

CODE

Angiofluor lots: 
5914AL, expiration date 1/1999
6202AL, expiration date 3/1999
6590AL, expiration date 8/1999
7020AL, expiration date 1/2000
7869AL, expiration date 11/2000 
8625AL, expiration date 8/2001.
AK-FLUOR lots: 
5836AK, expiration date 11/1998 
6299AK, expiration date 4/1999
6356AK, expiration date 5/1999
6590AK, expiration date 8/1999.

MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, New York.

RECALLED BY
Manufacturer, by telephone and by letter on November 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee and Illinois.

QUANTITY

Angiofluor:
Lot 5914AL:   16,248 units were distributed
Lot 6202AL:   55,308 units were distributed
Lot 6590AL:   50,112 units were distributed
Lot 7020AL:   10,868 units were distributed
Lot 7869AL:  104,016 units were distributed
Lot 8625AL:   99,372 units were distributed
AK-FLUOR: 
Lot 5836AK:   54,168 units were distributed
Lot 6299AK:   52,260 units were distributed
Lot 6356AK:   54,348 units were distributed
Lot 6590AK:   49,116 units were distributed.

REASON
Crystal formation.

________
PRODUCT
Doxepin Hydrochloride Capsules, USP, 10 mg, in unit doses packages of 100, oral Rx psychotherapeutic agent. NDC #51079-436-20. Recall #D-044-9.

CODE
Lot #8C521 EXP 3/00.

MANUFACTURER
Mylan, Inc., Caguas, Puerto Rico.

RECALLED BY
UDL Laboratories, Rockford, Illinois (repacker), by letter dated December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,503 unit cartons were distributed; firm estimated that 25% of product remained on market at time of recall initiation.

REASON
Product failed moisture limits testing (6 month stability).

________
PRODUCT
Colgate Cool-Mint Phos-Flur Anti-Cavity Fluoride Rinse, in 500 ml/16.9 fluid ounce bottles (Sodium Fluoride 0.044% (w/v)). NDC #0126-0135-46. Recall #D-045-9.

CODE
Lot #803069 EXP 3/00.

MANUFACTURER
Colgate Oral Pharmaceuticals, Dallas, Texas.

RECALLED BY
Manufacturer, by letter dated November 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
30,414 bottles were distributed.

REASON
Product cross contamination with alcohol and sodium cyclamate containing product.

________
PRODUCT

Various Rx drugs:
a) Metoprolol Tartrate Injection, 5 mg/5ml, in 5 ml single dose
vials, NDC #0364-3036-25 (Schein); b) Hydrocortisone Acetate
Injectable Suspension, USP, 25 mg/ml, in 10 ml multiple dose
vials, NDC #0402-0051-10 (Steris), NDC 0364-6624-54 (Schein);
c) Dexamethasone Acetate Injectable Suspension, USP, 8 mg/ml, in
5 ml multiple dose vials, NDC 0402-0092-05 (Steris)
NDC 0364-6699-53 (Schein)
NDC 0588-5344-75 (Keene)
NDC 0456-1075-05 (Forest)
NDC 0182-0928-62 (Goldline)
NDC 52384-068-05 (Teregen Labs)
NDC 63252-7644-3 (Radford Therapeutics);
d) Pentamidine Isethionate for Injection, lyophilized, 300 mg, in
single dose vials, NDC 0209-8560-20 (Marsam);
e) Methylprednisolone Acetate Injectable Suspension, USP, 40
mg/ml, in 10 ml multiple dose vials, NDC 0402-1069-10 (Steris)
NDC 0364-3064-54 (Schein)
NDC 57699-069-10 (A & G Pharmaceutical)
63252-1111-1 (Radford Therapeutics);
f) Methylprednisolone Acetate Injectable Suspension, USP, 80
mg/ml, in 5 ml multiple dose vials, NDC 0402-1070-05 (Steris)
NDC 0364-3065-53 (Schein)
NDC 55553-070-05 (Clint Pharmaceuticals)
NDC 63252-1112-5 (Radford Therapeutics)
NDC 0677-1539-20 (United Research Laboratories);
g) Estrone Injectable Suspension, USP, 5 mg/ml, in 10 ml multiple
dose vials, NDC 0402-0041-10 (Steris)
NDC 0364-6601-54 (Schein)
NDC 57699-041-10 (A&G Pharmaceutical)
NDC 0677-0274-21 (United Research Laboratories); 
h) Testosterone Injectable Suspension, USP, 100 mg/ml, in 30 ml
multiple dose vials, NDC 0402-0084-30 (Steris)
DIN 00616931 (Univet Pharmaceuticals);
I) Triamcinolone Diacetate Injectable Suspension, USP, 40 mg/ml,
in 5 ml multiple dose vials, NDC 0402-1071-05 (Steris)
NDC 0364-3081-53 (Schein)
NDC 0677-0981-20 (United Research Laboratories)
NDC 0182-3064-62 (Goldline)
NDC 0456-1060-05 (Forest)
NDC 11001-071-05 (San Jose Surgical Supply);
j) Vercuronium Bromide for Injection, Lyophilized Powder, 10 mg,
in 10 ml vials, NDC 0209-9140-22 (Marsam)
NDC 0209-9140-92 (Marsam)
NDC 0209-9141-26 (Marsam);
k) Vecuronium Bromide for Injection, Lyophilized Powder, 20 mg,
in 20 ml vials, NDC 0209-9143-22 (Marsam)
NDC 0209-9143-92 (Marsam).  Recall #D-046/056-9.

CODE

Lot numbers:  a) 98A910, 98B570, 98C250, 98C890;
b) 98A210; c) 98A280, 98A890; d) 98A480; e) 98B300;
f) 98B520, 98B960, 98C790; g) 98B250; h) 98B410;
I) 98B490, 98B940; 
j) 98A080, 98A260, 98A450, 98B090, 98B110, 98B330, 98B340,
98B540, 98B750, 98B770, 98C150, 98C270, 98C340, 98C530, 98C700,
98D080, 98D760;
k) 98A170, 98B120, 98B350, 98B780, 98C390, 98D110,
98D770.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on October 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Puerto Rico, Kenya, Africa, Nova Scotia, Canada.

QUANTITY
a) 231,465 vials; b) 9,044 vials; c) 168,557 vials; d) 6,088 vials; e) 35,934 vials; f) 173,188 vials; g) 3,484 vials; h) 1,925 vials; I) 138,733 vials; j) 674,440 vials; k) 67,730 vials were distributed.

REASON
Possible cross contamination with Triamcinolone Acetate.

________
PRODUCT
Cardizem Tablets (diltiazem HCl) 90 mg, in 100 tablet bottles, Rx for use in the management of chronic stable angina and angina due to coronary artery spasm. NDC #0088-1791-47. Recall #D-058-9.

CODE
Lot #98074588 EXP 5/2002.

MANUFACTURER
Hoechst Marion Roussel, Inc., Kansas City, Missouri.

RECALLED BY
Manufacturer, by letter on October 19, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,969 bottles were distributed.

REASON
Some of the tablets are missing identification (name/strength).

________
PRODUCT
Copaxone Injection (glatiramer acetate) 20 mg, in 2 ml vials, Rx, for subcutaneous use. NDC 0088-1150-03. Recall #D-059-9.

CODE
Lot numbers: 123304 EXP 12/99 and 123265 EXP 9/99.

MANUFACTURER
TEVA Pharmaceutical Industries, Ltd., Israel.

RECALLED BY
Hoechst Marion Roussel, Inc., Kansas City, Missouri, by telephone beginning November 4, 1998, and by fax on November 17, 1998. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Nationwide.

QUANTITY
2,343 32-vial patient packs were distributed.

REASON
Incorrect lot number and expiration date on a portion of outer shipping cases.

________
PRODUCT
Phazyme Maximum Strength Anti-Gas soft gelatin capsules (Simethicone), 166 mg, in bottles of 60, OTC for the relief of bloating, pressure and discomfort of gas. Recall #D-063-9.

CODE
Lot #H7645 EXP 6/99.

MANUFACTURER
Intergel, Irvington, New Jersey.

RECALLED BY
Block Drug Company, Inc., Jersey City, New Jersey, by telephone on June 11 and 12, 1998, followed by fax. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
38,448 bottles were distributed.

REASON
Batch mix-up - Some capsules are imprinted as 'sample' from a validation lot which was mixed with the distributed production lot.

________
PRODUCT
Sudafed(r) Non-Drowsy 12 hour Extended-Release (capsule shaped) Tablets, (Pseudoephedrine 120 mg), in bottles of 10 and 20, OTC for temporary relief of nasal congestion due to the common hold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. Recall #D-065-9.

CODE

SUDAFED(r)  Non-Drowsy 12 Hour Caplets
SUDAFED(r)  Non-Drowsy 12 Hour, 10 tablets/box
Lots 7C1613, 7C1614, 7C1615, 7C1616, 7C1617, 7C1618, 7C1620,
7C1621.   Expiration Date: 6/00,  NDC 0501-2787-10
Item No.:  22787-30
SUDAFED(r)  Non-Drowsy 12 Hour, 20 tablets/box, Lots 7D2067 &
7D2071  Expiration Date: 6/00,  NDC 0501-2787-20 
Item No.: 22831-30
SUDAFED(r)  Non-Drowsy 12 Hour Caplet Promotional Displays 
Cold Relief Center, Item #40927-00, UPC #12547-40927, Lots:
00497Y, 00597Y,00597YA, 00597YB, 00897Y, 00997Y, 00997YA,
00997YB, 00997YC, 00997YD, 00997YE, 00997YF, 00997YG
Expiration Date: 6/00 
Cough/Cold Shippers for K-Mart, Item #86833-00, UPC #12547-86833,
Lots: 02887C72, 02987C71, 02987C72, 02987C73 Expiration Date:
6/00
Permanent Unit with Cough/Cold Mix, Item #40929-00, 
UPC #12547-40929, Lot 02397C, 02397CA, Expiration Date: 6/00
Allergy/First Aid Permanent Display, Item #17124-01
UPC #12547-17124, Lot 02087C Expiration Date: 6/00
Note:  These promotional displays contain the following open
stock items:
Sudafed(r) 12 Hour Caplet 10's (contains 10 caplets per box and
72 boxes per case) NDC 0501-2787-10, Item No.:  22787-30
Lots: 7C1613, 7C1614, 7C1615, 7C1616, 7C1617, 7C1618, 7C1620,
7C1621 Expiration Date: 6/00;
Sudafed(r) 12 Hour Caplet 20's (contains 20 caplets per box and
72 boxes per case), NDC 0501-2787-20, Item No.: 22831-30
Lots 7D2067 & 7D2071 Expiration Date: 6/00.

MANUFACTURER
Catalytica Pharmaceuticals, Inc., Greenville, North Carolina (contract manufacturer).

RECALLED BY
Warner-Lambert Company, Morris Plains, New Jersey, by letters on February 16, 1998, April 15, 1998, followed by telephone. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
Firm estimated that little if any product remain on the market.

REASON
Dissolution failure.

________
PRODUCT
Sidmak brand Cyproheptadine HCL Tablets, USP, 4 mg, in 100 and 1,000 unit bottles, Rx, seasonal allergic rhinitis, colds, mild allergic skin manifestations. NDC #50111-314-01 (100's), 50111-314-03 (1000's)Recall #D-066-9.

CODE
Lot # 0170095 EXP1/2000.

MANUFACTURER
Sidmak Laboratories, Inc., East Hanover, New Jersey.

RECALLED BY
Manufacturer, by letter faxed July 13 and 14, 1998, and mailed July 14, 1998, followed by telephone and second letter August 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
19,658 bottles of 100 and 1 bottle of 1000 tablets were distributed.

REASON
Superpotent (112.0-143.7%).

________
PRODUCT
Various Rx drugs: a) Sus-phrine Injectable Suspension (Epinephrine), 1.5 mg/ampul (1:200), 0.3 mL Sterile ampuls, a sterile, on-pyrogenic suspension for subcutaneous injection, under the Forest label. NDC #0456-0664-39; b) Meperidine Hydrochloride Injection, USP, 50 mg/mL, 30 mL Sterile Multiple Dose vial, a narcotic analgesic, under the Steris (NDC #0402-0947-30), Schein (NDC0364-3026-560 labels; c) Hydromorphone Hydrochloride Injection, USP, 50mg/5mL, 5 mL ampul, a narcotic analgesic, under the Marsam Pharmaceutical label. NDC #0209-4237-12. Recall #D-068/070-9.

CODE
Lot numbers: a) 97M040; b) 96M510; c) 96M830 and 97A680.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on November 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Missouri; b) Arizona, California, Colorado, Connecticut, Florida, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Texas, Virginia, Wisconsin, West Virginia; c) Nationwide.

QUANTITY
a) 87,610 ampuls; b) 2,648 ampuls; c) 16,750 ampuls were distributed.

REASON
Current Good Manufacturing Practice Deviations (Lack of or incomplete process validation).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Source Plasma; b) Cryoprecipitate. Recall #B-377/378-9.

CODE
Unit numbers: a) G-48595-072, G-50776-072, G-54026-072, G-54544-072, G-56845-072; b) G-40702-072.

MANUFACTURER
Alpha Therapeutic Corporation (ATC), Long Beach, California.

RECALLED BY
Alpha Therapeutic Corporation (ATC), Los Angeles, California, by letter dated either May 14, 1998 or October 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and Spain.

QUANTITY
a) 5 units; b) 1 unit was distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody.

________
PRODUCT
Red Blood Cells. Recall #B-386-9.

CODE
Unit #42M94816.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter November 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported living in an area designated as endemic for malaria.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CASS III

________
PRODUCT
a) Fresh Frozen Plasma; b) Frozen Plasma. Recall #B-350/351-9.

CODE
Unit numbers: a) 35FC06483; b) 35KB3503, 35FH18666, 35LW07645, 35V26555, 35Y34611.

MANUFACTURER
American Red Cross Blood Services, Roanoke, Virginia.

RECALLED BY
Manufacturer, by telephone on September 1, 1998, and by letter dated September 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia, West Virginia, Georgia.

QUANTITY
a) 1 unit; b) 5 units were distributed.

REASON
Blood products were prepared from whole blood units that had discrepant start and end times documented.

_______
UPDATE
Rochester Eye and Human Parts Bank, Rochester, New York recall of Corneas, Tissue Donor Numbers: 96-2-4514, 96-4-4737, 95-8-4028, 95-12-4337, which appeared in the December 30,, 1998 Enforcement has been reclassified as a Class III recall. Quantity should read: 7 corneas were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Information Management System for Mammography Practices. Recall #Z-187-9.

CODE
All copies of Mammoworks Version 2.6.

MANUFACTURER
Lumisys, Inc., (formerly Compurad), Tucson, Arizona.

RECALLED BY
Manufacturer, by memorandum April 16, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 483 units were distributed.

REASON
The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam.

_______
PRODUCT
McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 with Software Version 2.32.00/2.42.01. Recall #Z-188-9.

CODE
Serial Numbers: P61145, P71108, P71115, P71125, P71130, P71135, P71142, P71147, P71152, P71157, P71162, P71166, P71167, P71168, P71173, P71183, P71185, P71192, P71194, P71195, P71201, P71202, P71205, P71208, P71210, P71211, P71216, P71225, P71233, P71234, P71243, P71244, P71259, P71266, P71283, P71319, P71607, P71616, P71620, P71621, P71626, P71647, P71649, P71652.

MANUFACTURER
Alphamed, Inc., Norcross, Georgia.

RECALLED BY
Manufacturer, by returning product around June 1997. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
28 pumps with software version 2.32.00/2.42.01 were distributed.

REASON
The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set.

________
PRODUCT

DePuy Steri-cuff Disposable Tourniquet Cuffs 
a) Steri-Cuff, 12 in., White, Single, Part No. 2901-12-000;
b) Steri-Cuff, 18 in., Navy, Single, Part No. 2901-18-000;
c) Steri-Cuff, 24 in., Green, Single, Part No. 2901-24-000;
d) Steri-Cuff, 34 in., Orchard, Single, Part No. 2901-34-000;
e) Steri-Cuff, 12 in., White, Double, Part No. 2902-12-000;
f) Steri-Cuff, 18 in., Navy, Double, Part No. 2902-18-000;
g) Steri-Cuff, 34 in., Orchard, Double, Part No. 2902-34-000;
h) Steri-Cuff, 44 in., Sky Blue, Double, Part No. 2902-44-000. 
Recall #Z-341/348-9.

CODE
Lot numbers: a) S2HAL3; b) S1WAJ3, S2HAJ3, SX2AA3, and SY6AF3; c) SW9AH3, SY6AG3 and S2HAN3; d) SX2AB3, SY6AH3, S1WAL3, S2DAA3, S1WAF3, S1JAA3, S3BAP3 and S2HAR3; e) SV3AL3; f) SX2AC3, SY6AB3, S1WAK3 and S2HAK3; g) SX2AD3, S1WAH3 and SY6AJ3; h) SL3AG3, S1WAN3, SY6AK3 and SW1AP3.

MANUFACTURER
Depuy Albuquerque, Inc., Albuquerque, New Mexico.

RECALLED BY
Depuy Orthopaedics, Inc., Warsaw, Indiana, by letters on October 26, 1998, and November 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
10,931 units were distributed.

REASON
The Velcro strap is failing at the seam to the cuff causing the cuff to loosen during use.

________
PRODUCT

Zimmer Statak Soft Tissue Attachment Devices:
a)  Catalog No. 00-2344-050-00, Statak Soft Tissue
Attachment Device, suture anchor with attached suture, 2.5 mm
diameter Anchor/standard driver USP size 0 suture;
b) Catalog No. 00-2344-062-00, Statak Soft Tissue Attachment
Device, suture anchor with attached suture, 5.0 mm diameter
anchor/standard driver USP size 2 suture; 
c) Catalog No. 00-2344-072-00, Statak Soft Tissue Attachment
Device, suture anchor with attached suture, 3.5 mm diameter
anchor/standard driver USP size 2 suture; 
d) Catalog No. 00-2344-075-00, Statak Soft Tissue Attachment
Device, suture anchor with attached suture, 5.2 mm diameter
Anchor/standard driver USP size 2 suture; 
e) Catalog No. 00-2345-050-00, Statak Soft Tissue Attachment
Device, suture anchor with attached suture, 2.5 mm diameter
Anchor/small driver USP size 0 suture; 
f) Catalog No. 00-2345-052-00, Statak Soft Tissue Attachment
Device, suture anchor with attached suture, 2.5 mm diameter
Anchor/small driver USP size 2-0 suture.  
Recall #Z-349/354-9.

CODE
All lot numbers.

MANUFACTURER
Linvatec, Largo, Florida.

RECALLED BY
Zimmer, Inc., A Bristol-Myers Squibb Company, Warsaw, Indiana, by letter dated November 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
35,138 packets of 5 were distributed.

REASON
Open seals were found on the outer or inner pouches , thereby, compromising the sterility of the devices.

________
PRODUCT
CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9.

CODE
All ACS 180 Plus Analyzers with test definition AL software version.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
38 ACS 180 Plus Analyzers were distributed.

REASON
A software error for Troponin I analysis caused erroneous results.

________
PRODUCT
Centaur Sample Pipette Tips used with ACS:Centaur Automated Chemiluminescence System, to aspirate patient samples and to place the samples into reaction cuvettes. Recall #Z-360-9.

CODE
All pipette lot numbers which do not have a 'C' in the number. Also, a '5' digit barcode number is on the outside of the box.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio. Component Manufacturer - Pipette Tips: Carrera Corporation, Latrobe, Pennsylvania.

RECALLED BY
Chiron Diagnostics Corporation, Oberlin, Ohio, by sending a Field Bulletin (#24) by electronic mail on May 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
International.

QUANTITY
7 Centaur units which use the affected sample pipette tips.

REASON
A defect was found in the flange of the disposable sample pipette tips (part #572491) which are used on the ACS:Centaur Analyzer. The defect can cause a loss of vacuum and subsequent loss of sample volume which may allow the sample to leak unexpectedly from the probe tips resulting in erroneous test results. The defect was detected during in-house reliability testing.

________
PRODUCT
ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostic tests. Recall #Z-363-9.

CODE
All lot numbers for the ACS Centaur.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Germany and Italy.

QUANTITY
6 units were distributed.

REASON
Software errors for V1.0 which could lead to erroneous test results.

________
PRODUCT
Multi-calibrator used with the Express Analyzer to establish a master calibration curve for determination of specific assay concentrations in unknown patient samples: a) Catalog #132342; b) Catalog #112507. Recall #Z-364-365-9.

CODE
Lot Numbers: D45UK, E51UK, F21UK, F22UK, F40UK, G1UK, G61UK, M19UK, M39UK, H68UK, K6UK, K39UK, M4UK, A2WK. EXP dates 10/99, 9/97, or 3/98.

MANUFACTURER
Chiron Diagnostics Corporation, Irvine, California (calibrator).

RECALLED BY
Chiron Diagnostics Corporation, Oberlin, Ohio, by letter dated February 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
2,000 vials and 29,459 kits were distributed.

REASON
The value assignments for CO2 and Ca are incorrect.

________
PRODUCT
CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostic tests. Recall #Z-368-9.

CODE
All serial numbers for the ACS 180 and ACS 180 Plus Analyzers.

MANUFACTURER
Chiron Diagnostics Corp., Oberlin, Ohio.

RECALLED BY
Manufacturer, by letter dated June 14, 1996. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,015 units were distributed.

REASON
Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements.

________
PRODUCT
CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall #Z-369-9.

CODE
All lot numbers for ACS 180 SE Analyzers.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete.

DISTRIBUTION
Texas, Virginia, Massachusetts, Kentucky, New York, New Jersey, Maryland, Astralia,Belgium, France, UK, Spain.

QUANTITY
15 units were distributed.

REASON
Software error causes 16 different assays to not calculate SI units correctly.

________
PRODUCT
Vision FX Series Digital Nuclear Imaging System, Models FX-40 and FX-80 Series, used in hospitals and diagnostic centers to produce tomographic images of the body which can aid in the diagnosis of aliments such as cancer and heart disease. Recall #Z-375/376-9.

CODE
Serial Nos. 93 to 96, 98, 100 to 120, 122 to 173, 70090080-00172 and 70090080-00173.

MANUFACTURER
SMV America Twinsburg, Ohio.

RECALLED BY
Manufacturer, by letter dated September 21, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and Guatemala.

QUANTITY
78 units were distributed.

REASON
The published specification for the maximum Imaging Count Rate is 250 kcps; however, the units can only achieve 215 kcps.

_______
UPDATE: Information published in the December 23, 1998 Enforcement report is being replaced with the following: PRODUCT: TDx\TDxFLx Flecainide Reagent Pack, list no. 9799-60, 100 tests; an in vitro diagnostic test for the quantitative measurement of flecainide acetate in serum or plasma. These measurements are used in monitoring levels of flecainide, an antiarrhythmic drug, to ensure appropriate therapy in treating life-threatening ventricular arrhythmias: a) List 9799-60, the Reagent Pack sold alone b) List 9799-69, the Flecainide Assay System, which includes the Reagent Pack, Cuvettes and Sample Cartridges. Recall Z-251/252-9.

CODE
Lot numbers 34103M400, 39703M100, 39889M100, 41527M100, 43789M300, and 44746M100.

MANUFACTURER
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois.

RECALLED BY
Manufacturer, by letters dated November 11, 1998, December 29, 1998. Firm-initiated field correction (labeling) ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,173 kits were distributed; firm estimated that 60 percent of the product remained on market at time of recall initiation.

REASON
The Flecainide Fluorescein Tracer has caused problems with assay calibration and controls out of range.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
90 Degree Child Osteotomy Plate 9.5 x 30mm Blade, 8 mm Offset, Product #235.2262, intended for use in intertrochanteric osteotomies, for derotation and varus osteotomies in small children up to 8 years of age. Recall #Z-330-9.

CODE
Lot #A4HP898.

MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.

RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter dated on November 19, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania, Texas, Missouri, Tennessee.

QUANTITY
113 units.

REASON
Product was labeled as 9.5 x 30mm but was 9.5 x 38mm.

________
PRODUCT

Bayer Immuno 1 System Pinch Valve Wash Tubing, sold separately
and as a component of kits  (Note:  Tubing in bags that do not
contain a piece of paper with the Part #156-2217-01 printed on it
are subject to recall:
a) Bayer Immuno 1 System Pinch Valve Wash Tubing 
(Part No. 156-2217-01);
b) Bayer Immuno 1 System 3 Month Preventative Maintenance Kit
(Part No. 156-B463-05);
c) Bayer Immuno 1 System Spares Kit (Part No. 156-2217-01).
Recall #Z-355/357-9.

MANUFACTURER
Bayer Corporation, Elkhart, Indiana.

RECALLED BY
Manufacturer, by letter on or about September 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 25,000 bags were distributed.

REASON
The devices may fail prematurely.

________
PRODUCT
RotaLink Exchange Catheter, Catalog No. 22768 (1.50 mm Burr Size), used with the Rotablator Rotational Angioplasty System. Recall #Z-358-9.

CODE
Lot numbers: C00005154, C00005174, C00005191, C00005204.

MANUFACTURER
Heart Technology Manufacturing, Inc., doing business as Boston Scientific NW Technology Mfg, Inc. (BSC NW), Redmond, Washington.

RECALLED BY
Manufacturer, by E-mail and fax beginning on October 20, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
124 units were distributed.

REASON
Some of the burr blanks had an out-of-specification inside dimension that will not allow passage of a guide wire through the lumen of the burr and driveshaft coil, preventing use of the device.

________
PRODUCT
APO A-1 & APO B Calibrator sets, used to calibrate express reagents for accessing cardiac risk by measuring apolipoprotein. Recall #Z-361/362-9.

CODE
a) Kit Lot #M47SK; Reagent Lot #'s: K47S, K48S, K49S, K50S, K51S, Catalog #140941; b) Kit Lot #M48SK, Reagent Lot #'s: K54S, K55S, K56S, K57S, K58S, Catalog #141441, EXP date: 4/97.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by telephone beginning June 3, 1996. Firm-initiated recall complete.

DISTRIBUTION
New Jersey, Michigan, California, Massachusetts and France.

QUANTITY
34 APO A1 kits and 35 APO B kits were distributed.

REASON
APO A1 and APO B value assignments contain a transcription error.

________
PRODUCT
CIBA Corning ACS:180 Analyzer, Catalog #1458X3XX, used to conduct various laboratory diagnostic test. Recall #Z-366-9.

CODE
All lot numbers for ACS 180 Analyzer.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by letter mailed on April 18, 1996, and May 21, 1996. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,673 units were distributed.

REASON
The probe may miss the sample tube if the 12 x 75 size patient tubes are used.

________
PRODUCT
Express Cuvettes for Models 550 and 560 Express Analyzer, used to conduct various laboratory diagnostic tests. Recall #Z-367-9.

CODE
Cuvettes lot numbers: 840677 through 840689, Catalog #751060 - Cavity 64.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio. Carrera Corporation, Export, Pennsylvania (component).

RECALLED BY
Manufacturer, by telephone on January 29, 1997, followed by letter. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Brazil.

QUANTITY
40 boxes (100 cuvette magazines per box) were distributed.

REASON
Some of the reaction Cuvettes, Cavity 84, may have small holes in the bottom allowing sample fluid to leak out which may possibly lead to false test results.

________
PRODUCT
Multi-calibrators 1 & 2 used with the Express System, to calibrate numerous chemical assays. Recall #Z-370-9.

CODE
Lot Numbers: D45UK and E51UK. Catalog Number: 132342 EXP Date: 10/99.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio. Chiron Diagnostics Irvine, California (calibrator).

RECALLED BY
Chiron Diagnostics Corporation, Oberlin, Ohio, by letter dated June 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,422 kits were distributed.

REASON
The Urea/Urease SI units were printed incorrectly on the Assay Values sheet for the Multi-Calibrator kits. As a result, the control and patient assays will be incorrect.

________
PRODUCT
Ammonia Reagent Kit used with Express Analyzer for determination of ammonia in blood serum. Recall #Z-371-9.

CODE
Lot Number: K73TK, Serial Number: 220241, Catalog Number: 220241, EXP Date: 4-98.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by telephone March 17, 1997. Firm-initiated recall complete.

DISTRIBUTION
International.

QUANTITY
35 kits were distributed.

REASON
The GLDH enzyme was contaminated with urease which caused the serum ammonia assay values to be out of linear range. The results were extremely high and the unit flagged with an 'over range'. The results were invalid and required to be run again. The contamination was not detected by the firm during incoming inspection and was used to manufacture the Ammonia Kits.

________
PRODUCT
Immunoglobulin (Ig) Calibrator which is used with the Express Analyzer to calibrate immunogloblin assays on the Express Analyzer. Recall #Z-372-9.

CODE
Information: Lot Number: A8422, Catalog Number: 106173, EXP Date: 4/97.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio. Component Manufacturer of the Kits: RaiChem Inc., San Diego, California (this firm mislabeled the calibrators).

RECALLED BY
Chiron Diagnostics Corporation, Oberlin, Ohio, by telephone on December 6, 1996. Firm-initiated recall complete.

DISTRIBUTION

Hong Kong.

QUANTITY
1 kit was distributed.

REASON
The Ig Calibrator Level 1, Lot #A8422C; and Ig Calibrator Level 3, Lot #A8422E, labeled October 09, 1996, were mis-labeled. The vial labels were switched by the manufacturer. As a result, the assays will not calibrate and the Analyzer will stop and not run further controls.

END OF ENFORCEMENT REPORT FOR JANUARY 13, 1998. BLANK PAGES MAY FOLLOW.

####