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.
ENFORCE
10/05/1994
Recalls and Field Corrections: Foods -- Class I -- 10/05/1994
October 5, 1994 94-40
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Cold Smoked Salmon Fillets, vacuum packed, pre-sliced, ready
to eat, labeled as Norwegian Salmon. Recall #F-839-4.
CODE Lot numbers 380 and 381.
MANUFACTURER Sotra Smoked Fish U.S.A., Inc., Kingston, New York.
RECALLED BY Manufacturer, by letter July 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION New York, Vermont.
QUANTITY 134.92 pounds were distributed; firm estimates none remains
on the market.
REASON Product was contaminated with Listeria monocytogenes.
_______________
PRODUCT Casey's Chesapeake Bay's Finest Crabmeat, denoted on
container lids as Jumbo, Lump, Special, Backfin, or claw,
packaged in plastic 1 pound containers. Recall F-840-4.
CODE None. All crabmeat produced 7/11/94.
MANUFACTURER Casey's Seafood, Inc., Newport News, Virginia.
RECALLED BY Manufacturer, by telephone on or about July 18, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, New Jersey, Virginia.
QUANTITY 590 pounds.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Torte Loaf Cheeses in approximate 1/2 pound (random weight)
packages, under the following labels: Dutch Garden Torte
Loaf, Swiss-American Inc., and Schnucks Torte Loaf Layered
Cheese Cold Pack Cheese Food. Recall #F-844-4.
CODE Pull dates ranging from 09-09-94 to 09-11-94.
MANUFACTURER Swiss American Importing Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone August 11 and 12, 1994, followed
by visit. Firm-initiated recall complete.
DISTRIBUITON Missouri, Illinois, Indiana, Kansas, Texas, Louisiana.
QUANTITY 301 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Salted Schmaltz Herring, Whole/Dressed, sold in 30 pound
pails. Recall #F-852-4.
CODE None.
MANUFACTURER Gold Star Smoked Fish, Woodbridge, Ontario, Canada.
RECALLED BY Beluga Caviar International Foods, Inc., Brooklyn, New York,
by telephone August 17, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Various crabmeat in 1 pound containers:
(a) Backfin; (b) Claw; (c) Cocktail Claw Fingers;
(d) Jumbo Lump; (e) Lump. Recall #F-859/863-4.
CODE None. All product manufactured between July 11, 1994 to
August 11, 1994.
MANUFACTURER Donald Johnson Seafood, Inc., Coden, Alabama.
RECALLED BY Manufacturer, by telephone August 3, 1994, and on or about
August 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, Louisiana, Pennsylvania.
QUANTITY (a) 4,030 pounds; (b) 1,264 pounds; (c) 2,468 pounds; (d)
2,287 pounds; (e) 8 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Swiss cold pack cheese food:
(a) Swiss Almond Cold Pack Cheese Food in 5 pound tubs; (b)
Swiss Cheese Cold Pack Cheese Food in 10 pound tubs.
Recall #F-864/865-4.
CODE (a) Pull date of FEB 15 - 95B; (b) Pull date of FEB 15 - 95.
MANUFACTURER Fromageries Bel, Inc., Hilbert, Wisconsin.
RECALLED BY Fromageries Bel, Inc., Fort Lee, New Jersey, by telephone
August 11 and 12, 1994. Firm-initiated recall complete.
DISTRIBUTION (a) Missouri; (b) Ohio.
QUANTITY (a) 25 cases (2 tubs per case); (b) 13 cases (2 tubs per
case) were distributed.
REASON Product is contaminated with Listeria monocytogenes.
-2- _______________
PRODUCT Hansen's Sneakers Bar Light Ice Cream, in 1/2 gallon and
2-1/2 gallon sizes. Recall #F-866-4.
CODE 223 (Julian date on the bottom of each of the product
containers).
MANUFACTURER Hansen's Dairy, Inc., Green Bay, Wisconsin.
RECALLED BY Manufacturer, by telephone September 1, 1994, followed by
letter September 2, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Michigan.
QUANTITY 234 half-gallon containers and 20 of the 2-1/2 gallon
containers were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Hilton's Condensed New England Style Clam Chowder, in 10 1/2
ounce cans. Recall #F-848-4.
CODE SEP96 SEP96 SEP96 SEP96
E2633 F2633 G2633 H2633
MANUFACTURER Borden, Inc., Cape May, New Jersey.
RECALLED BY Borden, Inc., Columbus, Ohio, by letter November 22, 1993.
Firm-initiated recall complete.
DISTRIBUTION South Carolina, North Carolina, Kentucky, Tennessee,
Alabama, Nebraska, Kansas, Indiana, Illinois.
QUANTITY 34,824 cans were distributed.
REASON Product contains ingredients that are not listed on the
label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Salsa, in 14 ounce plastic tubs. Recall #F-841-4.
CODE 7/27 pull date.
MANUFACTURER Essential Foods, Inc., Seattle, Washington.
RECALLED BY Manufacturer, by visit July 6, 1994. Firm-initiated recall
complete.
DISTRIBUTION Washington State.
QUANTITY 162 cases (12 units per case) were distributed.
REASON Product is contaminated with yeast.
_______________
PRODUCT Bottled Water, in 16 ounce, 1 liter and 2 liter plastic
bottles, under the Springtime and Flowing Well labels.
Recall #F-846/847-4.
CODE 3/22/95C, 4/18/95C, 4/19/95C, 5/09/95C, 5/27/95C, 5/31/95C
(Springtime label); 3/21/95C (Flowing Well label).
MANUFACTURER Southern Beverage Packers, Inc., Harlem, Georgia.
RECALLED BY Manufacturer, by visit on or about July 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION Southeastern United States.
-3- QUANTITY 5 million containers were distributed; firm estimates none
remains on the market.
REASON Product contained brown precipitates.
_______________
PRODUCT Maple Walnut Ice Cream, in 3 gallon containers.
Recall #F-855-4.
CODE Product manufactured from 3/6/94 through 9/6/94.
MANUFACTURER Schneider's Dairy, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter August 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little, if any, product remain on the
market.
REASON Product contained undeclared walnuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Cephradine Capsules USP, 500 mg, antibiotic, in bottles of
100. Recall #D-393-4.
CODE Lot numbers: 51642 EXP 9/1/94.
MANUFACTURER Biocraft Laboratories, Inc., Fairfield, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by
telephone June 24-28, 1994, followed by letter June 30,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,245 bottles were distributed; firm estimates less than 10%
of product remains on the market.
REASON Potency not assured through expiration date.
_______________
PRODUCT Brompheril Extended Release Tablets, OTC antihistamine/nasal
decongestant, under the following labels: Copley - in 100
tablet bottles, 10 tablet blister cards, 20 tablets (2
blister card of 10's/box); Goldline - 100 tablets; Roberts
Pharmaceutical blister card of 10 tablets. Product is sold
in bulk units of 500 blister cards, 10 tablets per cards
under the following labels: Granutec, LNK International,
Leiner, P., Perrigo, Private Formulation, Rempak Industries,
Republic Drug, Roberts Labs, Weeks & Leo. Recall #D-394-4.
CODE All lots with EXP 9/94 through EXP 1/96.
MANUFACTURER Copley Pharmaceutical, Inc., Canton, Massachusetts.
RECALLED BY Manufacturer, by letter September 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 54,914,680 tablets were distributed.
REASON Lack of assurance that the coating process was performed as
reflected in the batch records.
-4- _______________
PRODUCT Compazine Syrup, brand of Prochlorperzine Edysilate, 5 mg/5
ml and 4 fluid ounces, indicated for control of severe
nausea, vomiting, and for management of manifestations of
psychotic disorders. It is also effective for the short-
term treatment of generalized non-psychotic anxiety.
Recall #D-395-4.
CODE All lots ending in C63.
MANUFACTURER Smithkline Beecham Pharmaceuticals Company, Cidra, Puerto
Rico.
RECALLED BY Manufacturer, by letter September 12, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 112,986 packaged units were distributed; firm estimates
7,000 units remain on the market.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Various OTC drugs in various sizes and containers. Products
are manufactured for own label (National Home Care Products
and Alert Health Products) and contract manufactured for
firm in Pine Bluff, Arkansas (Select brand).
Recall #D-391-4.
Alert Health Products:
1. Aspirin, 325 mg (5 gr), 100 tablets
2. Aspirin, 325 mg (5 gr), 300 tablets
National Home Care Products:
3. Ibuprofen 200 mg, 100 coated tablets
4. Ibuprofen 200 mg, 250 coated tablets
5. Extra Strength Pain Reliever Tablets (Acetaminophen),
100 coated tablets
6. Extra Strength Pain Reliever Caplets (Acetaminophen)
250 coated tablets
7. Extra Strength Pain Reliever Caplets (Acetaminophen)
100 coated tablets
8. Added Strength Pain Reliever Analgesic, 100 coated
tablets
9. Adult Strength Pain Reliever Analgesic, 100 coated
tablets
10. Adult Strength Pain Reliever, 250 coated tablets
11. Multi Symptom Cough & Cold Formula (non-aspirin),
100 coated tablets
12. Antihistamine w/decongestant, 100 coated tablets
Select brand:
13. Regular Strength Non-Aspirin Pain Reliever, 100 tablets
14. Extra Strength Non-Aspirin Pain Reliever, 30 tablets
15. Extra Strength Non-Aspirin Pain Reliever, 60 tablets
16. Extra Strength Non-Aspirin Pain Reliever, 100 tablets
17. Extra Strength Non-Aspirin Pain Reliever, 24 caplets
-5- 18. Extra Strength Non-Aspirin Pain Reliever, 50 caplets
19. Extra Strength Non-Aspirin Pain Reliever, 100 caplets
20. Fast Acting Pain Reliever, 30 tablets
21. Fast Acting Pain Reliever, 50 tablets
22. Fast Acting Pain Reliever, 100 tablets
23. Antihistamine w/decongestant Blister, 24 tablets
24. Aspirin, 5 gr, 24 tablets
25. Aspirin, 5 gr, 50 tablets
26. Aspirin, 5 gr, 100 tablets
27. Multi Symptom Cold Relief Blister, 24 tablets
28. Docusate Sodium 100 mg Softgel, 60 softgels
29. Extra Strength Pain Reliever, 30 tablets
30. Extra Strength Pain Reliever, 60 tablets
31. Extra Strength Pain Reliever, 100 tablets
32. Ibuprofen 200 mg Caplets, 24 coated caplets
33. Ibuprofen 200 mg Caplets, 50 coated caplets
34. Ibuprofen 200 mg, 24 coated tablets
35. Ibuprofen 200 mg, 50 coated tablets
36. Sinus Tablets, 24 tablets
37. Enhanced Pain Reliever, 24 tablets
38. Safety Coated Aspirin, 100 tablets
39. Tri-Buffered Aspirin, 5 gr, 30 tablets
40. Tri-Buffered Aspirin, 5 gr, 60 tablets
41. Tri-Buffered Aspirin, 5 gr, 100 tablets
42. Chlorpheniramine 4 mg Blister, 24 tablets
43. Children's Fruit Non-Aspirin Pain Reliever, 30 chewable
tablets
44. Children's Grape Non-Aspirin Pain Reliever, 30
chewable tablets.
CODE All lots of all OTC drugs produced in the past calendar year
as follows:
1. A4-22, D4-24, D4-25, G4-08, H4-58, J4-35, J4-36, J4-37,
J4-38, O3-36, S3-26, S3-27, S3-28.
2. A4-21, A4-22, D4-23, D4-24, G4-07, H4-57, H4-58, H4-59,
J4-38, O3-36, S3-26, S3-27, S3-28, U3-57
3. K4-55, P3-52
4. K4-55, P3-52
5. J4-66, T3-63, T3-65
6. A4-33, D4-27, G4-64, U3-51
7. A4-33, G4-62, G4-64, U3-51
8. T3-66
9. S3-22
10. S3-22
11. B4-82, S3-49
12. J4-63
13. A4-34, D4-20, S3-44
14. T3-62, T3-63
15. O3-38, T3-62, T3-63, T3-65
16. J4-66, O3-38, S3-46, T3-63, T3-64, T3-65
17. A4-33, D4-26, G4-64
18. A4-33, D4-26, G4-63, G4-64, O3-43, O3-44, S3-45, U3-51
-6- 19. A4-32, D4-27, D4-28, G4-62, G4-63, G4-65, O3-43, O3-44,
S3-45, U3-51
20. O3-37, S3-22
21. A4-31, O3-37, S3-13, S3-22
22. D4-29, D4-30, O3-37, S3-13, S3-22
23. G4-06, S3-48
24. D4-25, S3-25, U3-56
25. G4-07, H4-59, S3-25, U3-56
26. D4-25, G4-07, H4-59, J4-35, O3-36, S3-25, U3-56
27. G4-05, S3-49
28. G4-33, S3-34
29. G4-61, T3-66
30. S3-24
31. G4-61, S3-24, T3-66
32. P3-51
33. H4-24, I4-34, P3-51
34. P3-52
35. P3-52
36. U3-52
37. D4-21, S3-23
38. C4-87, F4-69, I4-30, P3-34, T3-61
39. U3-55
40. U3-55
41. O4-22, U3-55
42. U3-53
43. G4-04, G4-60, O3-39
44. S3-47, U3-54.
MANUFACTURER National Vitamin Company, Inc., Porterville, California.
RECALLED BY Manufacturer, by letter September 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Czechoslovakia, Mexico, Paraguay and other Latin
American countries.
QUANTITY (1) 54,441; (2) 35,417; (3) 1,694; (4) 366; (5) 643;
(6) 499; (7) 791; (8) 142; (9) 181; (10) 64; (11) 351;
(12) 40; (13) 12,128; (14) 11,307; (15) 12,946;
(16) 21,652; (17) 16,499; (18) 36,930; (19) 45,690;
(20) 3,619; (21) 6,587; (22) 9,648; (23) 18,394;
(24) 14,161; (25) 23,080; (26) 24,215; (27) 18,017;
(28) 2,448; (29) 10,166; (30) 5,194; (31) 8,637;
(32) 7,815; (33) 12,250; (34) 5,510; (35) 4,854;
(36) 7,911; (37) 7,035; (38) 21,653; (39) 2,415;
(40) 2,790; (41) 6,741; (42) 8,053; (43) 25,887;
(44) 17,095.
REASON Current good manufacturing practice deficiencies identified
by State of California Food and Drug Branch.
_______________
PRODUCT Drixoral Cough & Congestion Liquid Soft Gelatin Capsules, 10
capsules per blister pack. Recall #D-392-4.
CODE Lot #4H044 EXP 5/96.
MANUFACTURER R.P. Scherer North America, St. Petersburg, Florida.
-7- RECALLED BY Schering-Plough Healthcare Products, Memphis, Tennessee
(repacker), by telephone and by letter September 16, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 62,052 boxes were distributed.
REASON Presence of small quantities of acetaminophen.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT Matrx Life Defense Plus (LDP) Portable
Defibrillator/Monitor/Pacer. Recall #Z-1277-4.
CODE Serial numbers 0141, 0162, 0192, 0250, 0326, 0607, 0608,
0624, 0658, 0659, 0673, 0841, 0857-1503.
MANUFACTURER Nectochigi, Japan.
RECALLED BY Matrx Medical, Inc., Orchard Park, New York, by letter July
6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 656 units were distributed.
REASON The D3 diode fails on the DKG high voltage circuit boards
resulting in the unit displaying an 001 error code which
disables the device.
RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
==========================
_______________
PRODUCT (a) All unprotected "non-safety" electrode, disposable pre-
wired infant electrode with male pins, Part numbers: H82V,
H82P, H22V, H22P; (b) All unprotected "non-safety" lead
wires with male pins, Part numbers: ARBO N12, ARBO T12.
Recall #Z-1086-4.
CODE All codes.
MANUFACTURER (a) Arbo Medizin Technologie, GMBH;
(b) Merritt Industries, Costa Mesa, California;
RECALLED BY Arbo Medical, Inc., Stratford, Connecticut, by letter
November 29, 1993, and August 5, 1994. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 360,606 pieces; (b) 25,705 pieces were distributed.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.
_______________
PRODUCT Unprotected Cables and Leadwires used with Bard STAMP
Amplifier Systems and Bard Mapping Systems which could be
interfaced to an apnea monitor and to a power source.
Products were packaged separately and as a set as follows:
Cable, ECG Assembly, Item #200369
Cable, ECG 4-Lead, Item #200370
-8- ECG Assembly, ECG 4-Lead (set), Item #200254;
Distributed as a component of:
Stand Alone STAMPTM, Item #200186
LabSystem 3/STAMPTM, Item #200187
LabSystem 3/32 Channel STAMPTM, Item #200516
32 Channel Stand Alone STAMPTM, Item #200517
Cardiac Mapping System (CMS), Item #200433
Cardiac Mapping System Plus, Item #200437
Start-Up Kit (CSM), Item #200033. Recall #Z-1187/1188-4.
CODE All lots/codes.
MANUFACTURER Bard Electrophysiology Division, Tewksbury, Massachusetts.
RECALLED BY Manufacturer, by letter September 16, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 168 units.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
_______________
PRODUCT Lifepak 10 - Upper Case of the Lifepak 10, a portable
battery operated, pre-hospital and hospital defibrillator.
Recall #Z-1433-4.
CODE Upper case date codes 9401, 9402, 9403.
Lifepak serial numbers: 514 through 31659 (non continuous).
MANUFACTURER Physio-Control, Redmond, Washington.
RECALLED BY Manufacturer, by hand delivering letters beginning June 15,
1994. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 660 units were distributed.
REASON Holes were noted in upper cases of the Lifepak 10 which
could allow water to enter the unit and cause it to
malfunction.
_______________
PRODUCT Dual Channel SEP Stimulator used with the Sentinel Four
Neurological Monitor, Model SS102. Recall #Z-1434-4.
CODE All codes and serial numbers.
MANUFACTURER Axon Systems, Inc., Hauppauge, New York.
RECALLED BY Manufacturer, by letter August 23, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 131 units were distributed.
REASON The device could cause a burn in a patient by sending a
positive current into the body without a negative current
returning creating a positive net current being stored in
the body (capacitance effect).
-9- _______________
PRODUCT OptiCon Multi-Use Connector Adapter, Model AR3030, used on
fiberoptic delivery system for use with Laserscope lasers.
Recall #Z-1435-4.,
CODE Model AR030.
MANUFACTURER Xintec Corporation, Oakland, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan September 20, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 65 units.
REASON Device was found to modify certified Laserscope laser
systems in that the Laserscope safety interlocks in the
connector port would be overridden, allowing unnecessary
access to laser radiation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Rhesus Monkey Kidney Cell Culture (RHMK), used for isolation
of virus in clinical specimens. Recall #Z-1436-4.
CODE Catalog #70-103M, lot #3C0062.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone February 29, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and Jeddah.
QUANTITY 1,388 units were distributed.
REASON The RHMK device was contaminated with a fungus identified as
Streptomyces species. This has the potential for causing
inaccurate test results when testing a patient for viral
infection.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Listeria Selective Supplement (MOX) Test Kit, a freeze-dried
selective supplement for the isolation of Listeria
monocytogenes. Recall #V-063-4.
CODE Catalog #SR157E, lot 93031 EXP 10/94.
MANUFACTURER Unipath Ltd., Hampshire, England.
RECALLED BY Unipath Division of UL Canada, Inc., Ogdensburg, New York,
by letter May 30, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, New Jersey, Tennessee.
QUANTITY 90 vials were distributed.
REASON Failure of test kit to detect Listeria on meat/poultry.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Cattle-Swine Wormer Medicated Feed, for the treatment of
gastrointestinal worms and lung worms, in 50 pound bags.
Recall #V-062-4.
-10- CODE Lot #94080.
MANUFACTURER Mountaire Feeds, Inc., North Little Rock, Arkansas.
RECALLED BY Manufacturer, by letter dated July 18, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arkansas, Texas, Tennessee, Louisiana, Mississippi.
QUANTITY 76 bags were distributed; firm estimates none remains on the
market.
REASON Product was subpotent in levamisole hydrochloride.
-11-
END OF ENFORCEMENT REPORT FOR OCTOBER 5, 1994. BLANK PAGES MAY
FOLLOW.
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