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.
October 30, 1996 96-44
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Various Noah Bagel products:
(a) Lox Cream Cheese Schmear
(b) Light Lox Cream Cheese Schmear
(c) Acme Smoked Nova Snacks
(d) Acme Pastrami Style Nova
(e) Acme Sliced Smoked Salmon.
Recall #F-018/022-7.
CODE (a and b) All product coded with manufacture
date of August 5, 1996, or earlier; (c, d and
e) All product coded with lot 192361 and below
and/or received by the firm 7/30/96 or earlier.
MANUFACTURER (a and b) Noah's Bagels, San Leandro,
California and Noah's Bagels, Whittier,
California; (c, d, and e) Acme Smoked Fish
Corporation, Brooklyn, New York.
RECALLED BY Noah's Bagel's, Alameda, California, by press
release dated August 5, 1996, followed by
notice sent to store managers. Firm-initiated
recall complete.
DISTRIBUTION California, Oregon.
QUANTITY Firm estimates none remains on the market.
REASON Products are contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Heinz Apple-Prune Juice for infants, in 4 ounce
bottles. Recall #F-023-7.
CODE All codes.
MANUFACTURER Heinz U.S.A., Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter on August 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 12,000 cases (24 bottles per
case) were distributed.
REASON Product contains lead in excess of the level of
concern of 80 ppb.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Various Wildflower Pharmacal Rx Tablet
Products:
(a) Spacol Tablets - Rx, in bulk box, prepared
for: Propharma Inc., Miami, FL
(b) Touro LA tablets - Rx, in bulk box,
prepared for: Propharma Inc,. Miami, FL.
Recall #D-020/021-7.
CODE (a) WPC lot #s: 930963, 940213, 941095 &
950557; (b) WPC lot #: 940320
MANUFACTURER Wildflower Pharmacal Corporation (WPC),
Mineola, New York.
RECALLED BY Manufacturer, by letter on August 21, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Mississippi, Tennessee, Florida, Louisiana.
QUANTITY (a) Spacol:
lot #930963 - 208,000 tablets, dist. 9/93;
lot #940213 - 288,000 tablets, dist. 2/94;
lot #941095 - 250,000 tablets, dist. 10/95;
lot #950557 - 309,000 tablets, dist. 5/95;
(b) Touro LA:
lot #940320 - 504,000 tablets, dist. 3/94.
REASON Good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Various Wildflower Pharmacal Rx Tablet
Products:
(1) Urogesic Blue tablets - Rx, urinary
antiseptic, in bottles of 4 and 100 tablets,
manufactured for Edwards Pharmaceuticals, Inc.
Ripley, MS
(2) Uro Blue tablets - Rx, urinary antiseptic,
in bottles of 100 tablets, manufactured for R.
A. McNeil, Chattanooga, TN
-2- (3) Urimar-T tablets - Rx, urinary antiseptic,
in bottles of 4, 8 and 100 tablets,
manufactured for Marnel Pharmaceuticals,
Lafayette, LA 70506.
(4) Prosed DS tablets - Rx, in bottles of 100
tablets, manufactured for Star Pharmaceuticals,
Inc. Pompano Beach, FL
(5) Urolene Blue tablets - Rx, in bottles of
100 and 1000 tablets labeled in part; "***
urinary antiseptic stimulant to mucous
surfaces, manufactured for Star
Pharmaceuticals, Inc. Pompano Beach, FL
(6) Uretron DS tablets - Rx, in bulk box,
prepared for: Propharma Inc., Miami, FL
(7) Urin DS tablets - Rx, in bulk box labeled
in part; prepared for: Propharma, Inc.
(8) Urinary tablets HY 408 - Rx, in bulk box,
Prepared for: Propharma, Inc., Miami, FL
(9) Urodol Tablets - Rx, in bulk box, prepared
for: Propharma, Inc. Miami, FL
(10) Helmitol Tablets - Rx, indicated for the
relief of inflammation and pain accompanying
lower urinary tract infection, in bulk box
(13) Yohimbine HCl 5.4 mg tablets - Rx, in bulk
box, prepared for: Propharma, Inc., Miami, FL.
Recall #D-010/019-7 & D-022-7.
CODE Volume in commerce:
(1) Urogesic Blue - Wildflower Pharmacal Corp.
(WPC) lot #s: 940974, 941086, 950212, 950327,
950432 & 950556.
(2) Uro Blue - WPC lot #s: 940974, 941086 &
950606.
(3) Urimar T - WPC lot #s: 940974, 941082,
9412110, 950212, 950432, 950556 & 950606.
(4) Prosed DS - WPC lot #s: 941094, 950109,
950326, 950438 & 950601.
(5) Urolene Blue - WPC lot #s: 950216 & 950548.
(6),(7) & (8) Uretron DS, Urin DS and HY 408 -
WPC lot #s: 930423, 930861, 940427, 940646,
940647, 940974, 941082, 941087, 9412102,
9412107, 950214, 950432, 950549, 950709.
(9) Urodol - WPC lot #s: 930860, 931288 and
950434.
(10) Helmitol - WPC lot #s: 940437, 940865,
9412108, 950108 and 950551.
(13) Yohimbine HCl - WPC lot #s: 930532,
931183, 940429, 940867, 950105 & 950558.
MANUFACTURER Wildflower Pharmacal Corporation (WPC),
Mineola, New York.
RECALLED BY Manufacturer, by letter on August 21, 1996.
Firm-initiated recall ongoing.
-3-DISTRIBUTION Mississippi, Tennessee, Florida, Louisiana.
QUANTITY (1) Urogesic Blue:
lot #940974 - 651/100 tablet bottles,
distributed 9/94; lot #941086 -860/100 tablet
bottles & 1008/4 tablet bottles, distributed
10/94; lot #950212 - 576/100 tablet bottles &
2016/4 tablet bottles, distributed 2/95;
lot #950327 - 2016/100 tablet bottles & 5460/4
tablet bottles, distributed 3/95; lot #950432 -
624/100 tablet bottles, distributed 4/95; lot
#950556 - 1576/100 tablet bottles & 4000/4
tablet bottles, distributed 5/95;
(2) Uro Blue:
lot #940974 - 288/100 tablet bottles, dist.
9/94;
lot #941086 - 970/100 tablet bottles, dist.
10/94;
lot #950606 - 921/100 tablet bottles, dist.
6/95;
(3) Urimar T:
lot #940974 - 1094/100 tablet bottles, dist.
9/94;
lot #941082 - 13,564/100 tablet bottles, dist.
10/94;
lot #9412110- 2016/100 bottles, dist. 12/94;
lot #950212 - 1500/100 tablet bottles & 2016/8
tablet bottles, dist. 2/95;
lot #950327 - 1440/100 tablet bottles &
6326/100 tablet bottles, dist. 3/95;
lot #950432 - 2112/100 tablet bottles, dist.
4/95;
lot #950556 - 11,712/100 tablet bottles, dist.
5/95;
lot #950606 - 7968/8 tablet & 5000/4 tablet
bottles, dist. 6/95;
(4) Prosed DS:
lot #941094 - 100,000 tablets & 1812/100 tablet
bottles, dist. 10/94;
lot #950109 - 80,500 tablets & 2009/100 tablet
bottles, dist. 1/95;
lot #950326 - 2297/100 tablet bottles, dist.
3/95;
lot #950438 - 3063/100 bottles, dist. 4/95;
lot #950601 - 4055/100 tablet bottles, dist.
6/95;
(5) Urolene Blue:
lot #950216 - 1852/100 tablet bottles &
1250/1000 tablet bottles, dist. 2/95;
lot #950548 - 1032/100 tablet bottles &
110/1000 tablet bottles, dist. 5/95;
-4- (6-8) Uretron DS/Urin DS/HY 408:
lot #930423 - 281,500 tablets, dist. 4/93;
lot #930861 - 316,000 tablets, dist. 8/93;
lot #940427 - 270,000 tablets, dist. 4/94;
lot #940646 - 298,000 tablets, dist. 6/94;
lot #940647 - 285,000 tablets, dist. 6/94;
lot #940974 - 111,500 tablets, dist. 9/94;
lot #941082 - 423,000 tablets, dist. 10/94;
lot #941087 - 402,000 tablets, dist. 10/94;
lot #9412102- 584,000 tablets, dist. 12/94;
lot #9412107- 452,000 tablets, dist. 12/94;
lot #950214 - 506,000 tablets, dist. 2/95;
lot #950432 - 313,000 tablets, dist. 4/95;
lot #950549 - 510,000 tablets, dist. 5/95;
lot #950709 - 450,000 tablets, dist. 7/95;
(9) Urodol:
lot #930860 - 248,000 tablets, dist. 8/93;
lot #931288 - 233,500 tablets, dist. 12/93;
lot #950434 - 236,000 tablets, dist. 4/95;
(10) Helmitol:
lot #940437 - 294,000 tablets, dist. 4/94;
lot #940865 - 260,000 tablets, dist. 8/94;
lot #9412108- 278,000 tablets, dist. 12/94;
lot #950108 - 249,000 tablets, dist. 1/95;
lot #950551 - 483,000 tablets, dist. 5/95;
(11) Yohimbine HCl:
lot #930532 - 370,000 tablets, dist. 5/93;
lot #931183 - 358,000 tablets, dist. 11/93;
lot #940429 - 320,000 tablets, dist. 4/94;
lot #940867 - 360,000 tablets, dist. 8/94;
lot #950105 - 372,500 tablets, dist. 1/95;
lot #950558 - 361,000 tablets, dist. 5/95;
REASON Current good manufacturing practice
deficiencies.
_______________
PRODUCT Boehringer-Ingelheim's Catapres (clonidine
hydrochloride USP) Tablet, 0.3 mg, Rx in
bottles of 100, centrally acting alpha agonist
agent. Recall #D-023-7.
CODE Lot #115001A EXP 1/98
MANUFACTURER Boehringer Ingelheim Pharmaceuticals, Inc.,
Ridgefield, Connecticut.
RECALLED BY Manufacturer, by telephone on October 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,282 bottles were distributed.
REASON Product is not stable -- One lot failed
dissolution test after 12 months of storage
(labeled shelf life is 30 months).
-5-_______________
PRODUCT Quinine Sulfate Tablets, USP, 260 mg, indicated
for the prophylaxis and treatment of patients
with malaria. Recall #D-024-7.
CODE Lot Numbers: 3001-863 EXP 06/98
3001-864 EXP 06/98
3001-865 EXP 06/98
3001-866 EXP 06/98
3001-867 EXP 07/98
3001-868 EXP 07/98
3001-869 EXP 07/98
3001-870 EXP 07/98
3001-871 EXP 07/98
MANUFACTURER Zenith Laboratories Caribe, Inc., Cidra, Puerto
Rico.
RECALLED BY Manufacturer, by letter August 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Puerto.
QUANTITY 40,347 100-tablet bottles and 11 1000-tablet
bottles were distributed.
REASON Labeling mistakes on the outsert: Tablet
debossing is incorrectly described and does not
list the following excipients -- dibasic
calcium phosphate, sodium starch glycolate, and
colloidal silicone dioxide.
_______________
PRODUCT Stevens Scientific's Glucose Tolerance Drink,
orange, lemon lime, cola flavors, in 10 ounce
bottles, used to evaluate diabetes mellitus and
related diseases. Recall #D-025-7.
CODE Catalog #6804A, Lot #5144 EXP 5/24/96.
MANUFACTURER Stephens Scientific, Riverdale, New Jersey.
RECALLED BY Manufacturer, by letter sent on March 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 259 cases (24 bottles per case) were
distributed.
REASON Some orange-flavored 75 g bottle caps may
incorrectly state the concentration as 50g; the
face label states 75g.
_______________
PRODUCT Medical Oxygen in Size D, E, and mini
cylinders. Recall #D-026-7.
CODE All lot numbers in distribution as of 9/17.
MANUFACTURER DeSota Home Health Care, Inc., Arcadia,
Florida.
RECALLED BY Manufacturer, by visit on or about September
20, 1996. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 78 tanks were distributed.
REASON Good manufacturing practice deficiencies.
-6-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma. Recall #B-004/008-7.
CODE Unit numbers: (a) 40GT73435, 40GX11738,
40GR90082, 40GT76918, 40GV69325, 40GR94033,
40GR95206, 40GL34770, 40GW15943, 40GN41712,
40GE00809, 40GW21265, 40GL48610, 40FE16211,
40FR07467, 40LW02696, 40LN02725, 40LS05175,
40GJ04905, 40GK06874, 40LH04566, 40LW05451,
40FR11288, 40GJ07845, 40GH09760, 40FN24459,
40FN24691
(b) 40GW15943, 40FE16211, 40FR07467, 40LW02696;
(c) 40GL34770, 40GN41712, 40GK06874, 40LH04566,
40LW05451, 40GJ07845, 40GH09760
(d) 40GT73435, 40GX11738, 40GT76918, 40GV69325,
40GR94033, 40GR95206, 40GE00809, 40GW21265,
40LN02725, 40LS05175, 40GJ04905, 40FR11288,
40FN24459, 40FN24691
(e) 40GT73435, 40GX11738, 40GR90082, 40GT76918,
40GV69325, 40GR94033, 40GR95206, 40GW15943,
40GE00809, 40GW21265, 40GL48610, 40FE16211,
40FR07467, 40LW02696, 40LN02725, 40LS05175,
40GJ04905, 40FR11288, 40FN24459, 40FN24691.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated April 22, 25, or
May 2, 1996. Firm-initiated recall complete.
DISTRIBUTION Illinois, Iowa, Missouri, Puerto Rico, Florida,
Alabama, Kansas, California, Switzerland.
QUANTITY (a) 27 units; (b) 4 units; (c) 7 units; (d) 14
units; (e) 20 units were distributed.
REASON Blood products which tested negative for the
hepatitis B surface antigen (HBsAg) were
collected from a donor who previously tested
repeatedly reactive, confirmatory positive for
HBsAg.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-009/012-7.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
-7-RECALLED BY Manufacturer, by telephone on July 18, 1996,
followed by letter on or about August 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Indiana, Ohio, California.
QUANTITY (a) 59 units; (b) 22 units; (c) 5 units; (d) 3
units were distributed.
REASON Blood products were prepared from units of
whole blood that were collected in a manner
which could compromise the sterility of the
products.
_______________
PRODUCT Platelets. Recall #B-019-7.
CODE unit #KZ32425 (split product).
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on March 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of body piercing within one
year of donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Platelets for Further
Manufacture. Recall #B-022/025-7.
CODE Unit numbers: (a) S70982, T02949, S74892,
S89787, T00057, T01677, T05269
(b) S89787
(c) T02949, S74892, S89787, T01677
(d) T00057, T01677.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated August 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 7 units; (b) 1 unit; (c) 4 units; (d) 2
units were distributed.
REASON Blood products that tested negative for
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), Western blot
indeterminate, were collected from donors who
previously tested repeatedly reactive for anti-
HIV-1, Western blot negative.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-707-6.
CODE Unit numbers: 09P41405, 09P41406, 09P41411,
09P41412, 09FP09719, 09FP09720, 09FP09722,
09FP09725, 09FP09727.
-8-MANUFACTURER American Red Cross, Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone on July 11, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 9 units were distributed.
REASON Blood products were incorrectly tested for the
antibody to the hepatitis B core antigen (anti-
HBc).
_______________
PRODUCT Red Blood Cells. Recall #B-018-7.
CODE Unit #10FH18752.
MANUFACTURER American Red Cross Blood Services, Springfield,
Missouri.
RECALLED BY Manufacturer, by telephone on October 23, 1995,
followed by letter dated November 29, 1995.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Universal Clinical Workstation (UCW), Model
#90385, a generic display device with
networking and data management capabilities.
Recall #Z-036-7.
CODE Serial number range 385-00001 through 385-
106292 (non-inclusive).
MANUFACTURER SpaceLabs Medical, Redmond, Washington.
RECALLED BY Manufacturer, by letters on August 9, 1996, and
September 3, 1996. Firm-initiation field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 6,320 monitors have been installed since 1993.
REASON The monitor may dislodge from wall mounted
base.
_______________
PRODUCT First Medic 3-Lead ECG/Synchronizer Module, for
use with the First Medic 710 semi-automatic
defibrillator. Recall #Z-037-7.
CODE Date codes are used on the modules. The firm
will provide a date code range for these
modules.
MANUFACTURER Physio Control Corporation, Redmond,
Washington.
RECALLED BY Manufacturer, by letter on or about September
16, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 377 modules were distributed.
-9-REASON A power supply line in the 3 lead ECG/sync
module that has excessive noise characteristics
which is being communicated to the
defibrillator and intermittently interpreted as
valid information. This noise may cause the
defibrillator charge cycle to be interrupted or
the loss of all ECG information displayed on
the screen.
_______________
PRODUCT Radionics Disposable SMK (Sluijter-Mehta
Cannula) and Disposable RF-Pole (Top-XE)
Electrodes:
(a) Part No. SMK-C5, 5cm Length, Standard 4mm
Tip;
(b) Part No. SMK-C10, 10cm Length, Standard 5mm
Tip;
(c) Part No. SMK-C15, 15cm Length, Standard 5mm
Tip;
(d) Part No. SMK-C(10) (2), 10cm Length, Active
Tip Length 2mm;
(e) Part No. SMK-C(15) (10), 15cm Length,
Active Tip Length 10cm;
(f) Part No. SMK-C(15) (2), 15cm Length, Active
Tip Length 2cm;
(g) Part No. RF-Pole (6), 6cm Length, Active
Tip 5mm;
(h) Part No. RF-Pole (10), 10cm Length, Active
Tip 5mm. Recall #Z-041/048-7.
CODE All lot numbers beginning with 3, 4, 5; any lot
numbers/letter sequence with 6A, 6B, 6C and lot
number 6D12S.
MANUFACTURER Top Corporation, Tokyo, Japan.
RECALLED BY Radionics, Inc., Burlington, Massachusetts, by
letter on August 29, 1996, and by telephone
beginning on September 30, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Estimated total quantity shipped from 1/1/93 -
6/30/96: RF-Pole(10) -- 6,153 units;
RF-Pole(6) -- 2,510 units;
SMK-CF -- 13,371 units;
SMK-C10 -- 36,177 units;
SMK-C15 -- 16,943 units.
REASON Missing insulation at the point where the
cannula shaft and the hub meet, and/or a break
in the insulation would allow RF current to
pass into the surrounding tissue.
_______________
PRODUCT Ventritex Tiered Therapy
Cardioverter/Defibrillator Model V-115.
Recall #Z-053-7.
-10-CODE Various serial numbers.
MANUFACTURER Ventritex, Inc., Sunnyvale, California.
RECALLED BY Manufacturer, by letter on September 24, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29 units were distributed.
REASON A degradation of the pace/lead connection may
result in intermittent sensing or loss of the
sensing function and/or pacing output.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =======
_______________
PRODUCT Bausch & Lomb Optima Toric Contact Lenses.
Recall #Z-029-7.
CODE Various lot numbers.
MANUFACTURER Bausch & Lomb, Inc., Sarasota, Florida
(relabeler/responsible firm).
RECALLED BY Bausch & Lomb, Inc., Rochester, New York by
letter dated September 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 54,000 lenses were distributed; 196 of those
were mislabeled.
REASON The lens parameters, lot number and/or
expiration date are incorrect on the labeling.
_______________
PRODUCT Right Angle Feeding Kit, product #30-1802,
Gastrostomy feeding set for use with Corflo-
Dome LPGD (low profile gastrostomy device).
Recall #Z-033-7.
CODE Box lot #A92MP; set Lot #9514708.
MANUFACTURER Applied Medical Technology, Independence, Ohio.
RECALLED BY Manufacturer, by telephone on August 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 43 boxes (10 sets per box) were distributed;
firm estimates none remains on market.
REASON Some boxes of product were incorrectly labeled
as "Corflo-Dome LPGD", instead of being
properly labeled as "Right Angle Feeding Set.
_______________
PRODUCT Thromboplastin-D Reagent, 10 ml, diagnostic
used to perform Prothrombin Times on in-vitro
patient specimens and controls.
Recall #Z-040-7.
CODE Catalog #176-6999, Lot #357A01.
MANUFACTURER Pacific Hemostasis, Huntersville, North
Carolina.
-11-RECALLED BY Manufacturer, by letters on May 31, 1996 and
July 23, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Ecuador.
QUANTITY 2,866 kits were distributed.
REASON The reconstituted stability was less than
labeling indicated.
_______________
PRODUCT Compressed Ga Valve, Part #YVB5454-4875G, for
use on medical gas cylinders.
Recall #Z-054-7.
CODE Lot numbers: 26-94 to 52-94, 1-95 to 52-95, 1-
96 to 36-96.
MANUFACTURER Sherwood Division of Harsco Corporation,
Lockport, New York.
RECALLED BY Manufacturer, by letters from August 28, 1996,
to September 6, 1996, and September 16, 1996,
and October 2, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION California, Florida, Georgia, Kansas, Maryland,
Missouri, Minnesota, Ohio.
QUANTITY 3,306 valves were distributed.
REASON The valve is designed to handle gas pressures
of 3,000 PSI, but some cylinders were produced
with a pressure relief device designed for
2,000 PSI.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II =========
_______________
PRODUCT Radix Labs CMPK, in 500 ml bottles, an
injectable labeled as a nutritional supplement
for cattle, also marketed as CAL-DEX CMPK,
manufactured for Animal Health Associates,
Kansas City, Missouri. Recall #V-001-7.
CODE Lot # 950327 EXP 3/97.
MANUFACTURER Radix Laboratories, Inc., Eau Claire,
Wisconsin.
RECALLED BY Manufacturer, by letter September 4, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Minnesota, Missouri, Wisconsin.
QUANTITY 6,199 500 ml bottles distributed.
REASON Precipitate found in the injectable parenteral
product.
_______________
PRODUCT Fermycin Soluble Chlortetracycline
Hydrochloride antibiotic Soluble Powder, for
use in chickens, turkeys, swine and cattle.
Recall #V-017-7.
CODE All lots manufactured since 8/92.
-12-MANUFACTURER Fermenta Animal Health Company, Elwood, Kansas.
RECALLED BY Manufacturer, by telephone on September 3,
1996, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 446,046 26.6-ounce pouches and 100,908
6.4-ounce pouches were distributed.
REASON Inconsistencies in the process which caused
subpotent batches and superpotent batches which
were detected during process validation.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
_______________
PRODUCT Various DVM Pharmaceuticals products:
(a) ClearX Ear Cleanser
(b) ClearX Ear Dry Solution
(c) Corti Spray Therapeutic Spray
(d) CortiCalm Lotion
(e) Relief Creme Rinse
(f) SeboRX Shampoo
(g) OtiCalm Ear Cleanser
(h) Hylyt Hypoallergenic Creme Rinse
(i) Chlorhexi Derm Disinfectant
(j) Chlorhexi Derm Scrub
(k) LyTar Shampoo
(k) Chlorhexi Derm Shampoo
(l) Sulf OxyDex Shampoo
(m) OxyDex Shampoo
(n) SebaLyt Shampoo All-Purpose.
Recall #V-002/016-7.
CODE Lot numbers: (a) 26614, 35014, 06915, 13235,
15625, 27925
(b) 00315, 12215, 23445
(c) 155240, 157060
(d) 01815, 04725, 03725, 06865, 15345, 04715,
15355, 03725
(e) 4448, 5356, 4397, 4419, 5147, 5380, 5408
5457, 6021, 4471, 4811, 4911, 4497
(f) 4471, 4811, 4911, 4497
(g) 35325, 01116, 4406, 4428, 4433, 4440,
5353, 5376
(h) 8221
(i) 6002
(j) 5389, 158121
(k) 159190, 155290, 157290, 5217
(k) 40201, 597030, 4403, 4517
(l) 29125, 33335, 31925, 33335
(m) 28545, 25835, 33225
(n) 151050, 154240, 499211, 498211, 35615,
158140, 259140, 350380, 594120, 595120, 160110,
167160, 597020
MANUFACTURER DVM Pharmaceuticals, Inc., Miami, Florida.
-13-RECALLED BY Manufacturer, by letter on August 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 326,300 product units were distributed.
REASON Products were either assayed low for an active
ingredient, had missing certificate of
analysis, had insufficient stability data, or
appearance is out of specification.
-14-
END OF ENFORCEMENT REPORT FOR OCTOBER 30, 1996. BLANK PAGES MAY FOLLOW.
####
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