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.
December 23, 1998                     98-51

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT
Supreme Nova Bits (smoked salmon), packaged in 10 pound plastic pails. Recall #F-086-9.

CODE
132381.

MANUFACTURER
Banner Smoked Fish, Inc., (also known as Supreme Foods, Inc.), Long Island City, New York.

RECALLED BY
Manufacturer, by letter faxed on May 13, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Florida.

QUANTITY
150 pails were distributed; firm estimates none remains on the market.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT
Heinz Beginner Strained Carrots, in 2.5 ounce jars. Recall #F-095-9.

CODE
P31176N.

MANUFACUTRER
Heinz USA, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer:, by letter October 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
25,760 cases were distributed; firm estimates none remains on the market.

REASON
Product contains elevated levels of lead.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

PRODUCT
Nancy's Praline Pecans in 4 ounce cello bags. Recall #F-091-9.

CODE
Cases are identified with 092898SS.

MANFACTURER
Nancy's Homemade Fudge, Inc., Meadows of Dan, Virginia.

RECALLED BY
Manufacturer:, by telephone on or about November 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Virginia, Alabama, Mississippi, Louisiana, Florida, Iowa, Illinois, Michigan, Nebraska.

QUANTITY
Less than 12 cases (24 bags per case) were distributed.

REASON
Product's label does not specify the place of business of the manufacturer, packer, or distributor as required.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________ PRODUCT
Miostat (Carbachol 0.01%) Intraocular Solution, in 1.5 ml sterile glass vials, Rx, for use for obtaining miosis during surgery. NDC #0065002315 (United States) and 0065002310 (Canada). Recall #D-042-9.

CODE
All lots that remain within expiration date (84 lots).

MANFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letters dated November 16 and 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
1,981,956 units were distributed; firm estimated that 190,000 units remained on market at time of recall initiation.

REASON
Presence of minute borosilicate flakes.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________ PRODUCT
Oxygen, USP, in B & E high pressure cylinders. Recall #D-038-9.

CODE
Lot numbers: 081098, 081198, 081298, 0852598.

MANFACTURER
Lincare, Inc., Virginia Beach, Virginia.

RECALLED BY
Manufacturer, by telephone November 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and North Carolina

. QUANTITY
276 cylinders were distributed.

REASON
Current good manufacturing practice deviations.

________ PRODUCT
Diltiazem Hydrochloride, USP, Extended-Release Capsules, 60 mg, in 100 capsule bottles, used in the treatment of hypertension. NDC #0093-0021-01. Recall #D-039-9.

CODE
Lot numbers: 8425 EXP 7/99 and 8426 EXP 7/99.

MANFACTURER
Teva Pharmaceuticals, Sellersville, Pennsylvania.

RECALLED BY
Manufacturer, by letter on May 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
9,133 bottles of lot 8425 and 9,438 bottles of lot 8426 were distributed.

REASON
Dissolution failure (6 month stability).

________ PRODUCT
Rhinecort (budesonide) Nasal Inhaler, 7g, 200 metered doses, an anti-inflammatory glucocorticosteroid. NDC 0186-1075-09 and NDC 0186-1075-PS (Professional Sample). Recall #D-040-9.

CODE
Lot numbers and EXP dates: XM127 EXP 12/98, YA128 EXP 1/99, XM 126 EXP 12/98, YC 135 EXP 03/99, YC 136 EXP 03/99, YO 137 EXP 04/99, YD 139 EXP 04/99, YD 139 EXP 04/99, YE 140 EXP 05/99 YF 143 EXP 06/99, YG 144 EXP 07/99, YG 147 EXP 07/99 YG 148 EXP 07/99, YG 151 EXP 07/99, YG 152 EXP 07/99 YH 155 EXP 08/99, YI 159 EXP 09/99, YI 160 EXP 09/99 YI 161 EXP 09/99, YI 162 EXP 09/99, YK 163 EXP 10/99 YL 165 EXP 11/99, YL 166 EXP 11/99, YM 169 EXP 12/99 ZA 170 EXP 01/00, ZA 171 EXP 01/00, ZB 174 EXP 02/00 ZB 175 EXP 02/00, ZB 176 EXP 02/00, ZB 178 EXP 02/00 ZC 180 EXP 03/00, ZC 181 EXP 03/00, ZC 183 EXP 03/00 ZD 185 EXP 04/00, ZD 186 EXP 04/00, ZD 187 EXP 04/00 ZF 191 EXP 06/00, ZF 192 EXP 06/00, YB 129 EXP 02/99, YB 130 EXP 02/99, YB 131 EXP 02/99, YB 132 EXP 02/99 YC 133 EXP 03/99, YC 134 EXP 03/99, YE 141 EXP 05/99, YE 142 EXP 05/99, YG 145 EXP 07/99, YG 146 EXP 07/99 YG 149 EXP 07/99, YG 150 EXP 07/99, YH 154 EXP 08/99 YH 156 EXP 08/99, YH 157 EXP 08/99, Yl 158 EXP 09/99 YK 164 EXP 10/99, YK 167 EXP 11/99, YL 168 EXP 11/99 ZA 173 EXP 01/00, ZB 177 EXP 02/00, ZC 182 EXP 03/00 ZD 184 EXP 04/00, ZD 188 EXP 04/00.

MANFACTURER
3M Healthcare, Loughborough, UK

RECALLED BY
Astra USA, Westborough, Massachusetts, by letters issued the week of November 16, 1998, and on December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
92,484 units of Lot XM127, 89,748 units of Lot YA128, 50,000 to 100,000 retail units of all other lots and an undetermined amount of physician samples were distributed.

REASON
Product testing for total degradation does not support labeled expiration date.

________ PRODUCT
Requip(tm) Tablets (Ropinirole Hydrochloride), 0.25 mg, in patient starter packages (126 tablets), Rx used for treatment of signs and symptoms of idiopathic Parkinson's disease. NDC #489061. Recall #D-041-9.

CODE
Lot numbers: 680970 EXP 2/99 and 680990 EXP 2/99.

MANFACTURER
Smith Kline Beecham Pharmaceuticals, West Sussex, United Kingdom.

RECALLED BY
Smith Kline Beecham Pharmaceuticals, Philadelphia, Pennsylvania, by letter sent the week of September 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,730 packages of lot 680970 and 5,695 packages of lot 680990 were distributed. Firm estimates none remain on the market.

REASON
Degradation test data will not support labeled expiration date.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________ PRODUCT
Carticel (Autologous Cultured Chondrocytes). Recall #B-286-9.

CODE
Lot C81346.

MANFACTURER
Genzyme - Tissue Repair, Cambridge, Massachusetts.

RECALLED BY
Manufacturer, by telephone on August 22 and 24, 1998, and by letter dated September 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
North Carolina.

QUANTITY
1 vial was distributed.

REASON
Tissue repair product was contaminated with Staphylococcus capitis (coagulase negative).

________ PRODUCT
Red Blood Cells. Recall #B-289-9.

CODE
Unit numbers: FS27380 and GM81105

MANFACTURER
Central Blood Bank, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on March 26, 1997. Firm-initiated recall complete.

DISTRIBUTION
West Virginia and Illinois.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________ PRODUCT
Platelets. Recall #B-290-9.

CODE
Unit #8008054.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated February 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

________ PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma, Frozen. Recall #B-293/295-9.

CODE
Unit #GE11704.

MANFACTURER
Central Blood Bank, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer, by telephone and fax on September 17 and 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who was participating in a drug study.

________ PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-298/301-9.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANFACTURER
Collection Sites: American Red Cross Blood Services, Buffalo, New York; American Red Cross Blood Services, Syracuse, New York. Testing Lab.: American Red Cross - National Testing Laboratory, Dedham, Massachusetts.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letters between January 16, 1997 and February 5, 1998, and between June 24, 1998 and July 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, California, Switzerland.

QUANTITY
a) 183 units; b) 9 units; c) 15 units; d) 171 units were distributed.

REASON
Blood products were incorrectly tested for syphilis.

________ PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-306/307-9.

CODE
Unit #G20106.

MANFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated December 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose suitability was not adequately determined.

________ PRODUCT
Fresh Frozen Plasma. Recall #B-308-9.

CODE
Unit #8021128.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on June 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly labeled with the wrong ABO typing.

________ PRODUCT
a) Red Blood Cells; b) Plasma. Recall #B-309/310-9.

CODE
Unit #1439935.

MANFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.

RECALLED BY
Manufacturer, by letter dated January 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky and California.

QUANTITY
1 unit of each component was distributed.

REASON
: Blood products were collected from a door taking the drugs Tegretol and Minocin.

________ PRODUCT
Platelets, Pheresis. Recall #B-312-9.

CODE
: Unit numbers: 8027652 and 8027518.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
: Manufacturer, by letter dated July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Louisiana.

QUANTITY
: 2 units were distributed.

REASON
Blood products were collected from a donor taking the drug Carbamazepine.

________ PRODUCT
Red Blood Cells. Recall #B-313-9.

CODE
Unit #8011389.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on June 30, 1998 and by letter dated July 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

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

________ PRODUCT
Platelets. Recall #B-316-9.

CODE
Unit #8008009.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on November 16, 1997, and by letter dated November 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

________ PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-317/319-9.

CODE
Unit #5008256.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated January 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had ear piercing within 12 months of donation.

RECALLS AND FIELD CORRECTIONS: BILOGICS -- CLASS III

________ PRODUCT
Platelets. Recall #B-292-9.

CODE
Unit numbers: 0496394, 0496395, 0496396.

MANFACTURER
Blood Bank of Delaware, Newark, Delaware.

RECALLED BY
: Manufacturer, by letter on February 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Delaware.

QUANTITY
3 units were distributed.

REASON
Blood products were prepared more than eight hours after collection of whole blood.

________ PRODUCT
Source Plasma. Recall #B-296-9.

CODE
Unit numbers: 11-18691A and 11-18691B.

MANFACTURER
Biological Speciality Corporation, Colmar, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on January 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida and Virginia.

QUANTITY
2 units were distributed.

REASON
Blood products were distributed prior to testing for HIV-1 Ag.

________ PRODUCT
a) Recovered Plasma for Manufacturing Non-Injectables; b) Platelets for Manufacturing Non-Injectables. Recall #B-302/303-9.

CODE
Unit numbers: a) 31LG01234, 31LP01516; b) 31LC02233, 31LC02241.

MANFACTURER
Collection Sites: American Red Cross Blood Services, Buffalo, New York; American Red Cross Blood Services, Syracuse, New York. Testing Lab.: American Red Cross - National Testing Laboratory, Dedham, Massachusetts.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letters between January 16, 1998 and February 5, 1998, and between June 24, 1998 and July 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, California, Switzerland.

QUANTITY
: 2 units of each component were distributed.

REASON
: Blood products were incorrectly tested for syphilis.

________ PRODUCT
Red Blood Cells, Irradiated. Recall #B-311-9.

CODE
Unit #8017165.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated July 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________ PRODUCT
Platelets. Recall #B-314-9.

CODE
Unit 8006672.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on April 23, 1998, and by letter dated May 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
1 unit was distributed.

REASON
Blood product was not quarantined after receiving information concerning a post donation illness.

________ PRODUCT
Red Blood Cells, Irradiated. Recall #B-315-9.

CODE
Unit #8037149.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated September 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________ PRODUCT
Red Blood Cells. Recall #B-320-9. CODE
Unit #8028463.

MANFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on August 13, 1998, and by letter dated August 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor whose health history screening was inadequately performed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ PRODUCT
Flush Syringe Combination Package, 10u/ml. Recall #Z-172-9.

CODE
Lot number 10080-0821-1310-FL.

MANFACTURER
ROCAP Division of Sabratek Corporation, Orlando, Florida.

RECALLED BY
Manufacurer, by letter September 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
1 case of 40 units was distributed.

REASON
Some syringes labeled 10u/mL heparin actually contained normal saline.

________ PRODUCT
Abbott TDx/TDxFLx Estriol Reagent Packs; these reagents are used with either Total Estriol Calibrators (list 9112-01) or Free Estriol Calibrators (list 9118-01) in a Fluorescence Polarization Immunoassay (FPIA) in vitro diagnostic for the quantitative measurement of either total estriol or free estriol in human serum, plasma or urine:

a) TDx/TDxFLx Flecainide Reagent Pack, List No. 9799-60; b) TDx/TDxFLx Flecainide Assay System, List No. 9799-69. Recall #Z-251/252-9.

CODE
a) Reagent Lot Nos. 34103M400, 39703M100, 39889M100, 41527M100, 43789M300, 44746M100; b) Reagent Lot Nos. 34103M400, 39703M100, 39889M100, 41527M100, 43789M300, and 44746M100.

MANFACTURER
Abbott Health Products, Inc., Barceloneta, Puerto Rico.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letters on July 2 and 7, 1997. Firm-initiated recall ongoing.

DISTRIBUTION
California, Kentucky, Georgia, Illinois, Indiana, Louisiana, Maryland, West Virginia, Ohio, Pennsylvania, Texas, international.

QUANTITY
1,226 packs were distributed; firm estimated that 10% remained on market at time of recall initiation.

REASON
Use of product may result in assay calibration and/or quality control errors such "PO too small", "Range too large", or "Span les than Min Span" resulting in invalid calibration curves. In addition, once a valid calibration curve is obtained, controls may drift out of range.

________ PRODUCT
VENTAK Automatic Implantable Cardioverter Defibrillators, a) Model No. 1820, VENTAK AV II DDD AICD(tm) Automatic Implantable Cardioverter Defibrillator; b) Model No. 1821, VENTAK AV II DR AICD(tm) Automatic Implantable Cardioverter Defibrillator; c) Model No. 1826, VENTAK AV II DR AICD(tm) Automatic Implantable Cardioverter Defibrillator; d) Model No. 1831, VENTAK AV III DR AICD(tm) Automatic Implantable Cardioverter Defibrillator; e) Model No. 1836, VENTAK AV III DR AICD(tm) Automatic Implantable Cardioverter Defibrillator; f) Model No. 1810, VENTAK AV(tm) AICD(tm) Automatic Implantable Cardioverter Defibrillator; g) Model No. 1815, VENTAK AV(tm) AICD(tm) Automatic Implantable Cardioverter Defibrillator. Recall #Z-269/275-9.

CODE
All serial numbers.

MANFACTURER
Guidant Corporation, Cardiac Pacemakers, St. Paul, Minnesota.

RECALLED BY
Manufacturer, by letter sent on December 5, 1998. Firm-initiated action is a field correction which is ongoing. During the field correction, the defibrillators are being reprogrammed. The returned or explant of the defibrillators has not been requested.

DISTRIBUTION
Nationwide and international.

QUANTITY
13,851 defibrillators.

REASON
A rare interaction of the device's internal timing sequences has the potential to create a situation in which the defibrillators stop delivering pacing therapy for up to 24 hours. When this situation occurs, the device resumes pacing at the next daily battery measurement or whenever cardioversion/defibrillation therapy is delivered, making all therapies available. This anomaly can recur. Cardioversion/defibrillation therapy is always available.

________ PRODUCT
Heparin Flush Syringe 100 u/ml, 0.9% NS with specific volume fill, syringe size as follows: a) 5 cc in 6cc syringe; b) 10 cc in 12 cc syringe c) 5 cc in 12 cc syringe; d) 3 cc in 12 cc syringe; e) 3 cc in 6 cc syringe Examination #19980349. Recall #Z-300-9.

CODE
Lot # 04800252, 5 cc in 12 syringe, EXP date 5/26/99; Lot # 04800211, 5cc in 6 cc syringe, EXP date 5/6/99; Lot #04800239, 10 cc in 12 cc, EXP date 5/20/99; Lot #04800240, 5 cc in 12 cc syringe, EXP date 5/21/99; Lot #04800241, 5 cc in 12 cc syringe, EXP date 5/21/99; Lot #04800258, 5 c in 12 cc syringe, EXP date 5/27/99; Lot #04800272, 3 cc in 12 cc syringe, EXP date 6/1/99; Lot #04800278, 3 cc in 6 cc syringe, EXP date 6/3/99; Lot #04800282, 5 cc in 12 cc syringe, EXP date 6/4/99.

MANFACTURER
Central Admixture Pharmacy Services, Inc., Miami Lakes, Florida.

RECALLED BY
Manufacturer, by telephone on October 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, New Jersey, Washington state, Texas, New York, Vermont, New Hampshire, Maine.

QUANTITY
Approximately 4,000 syringes were distributed.

REASON
Stability Data for the heparin flush 10 u/ml syringes can support only a 60 day expiration date. The nine lots listed above has incorrect expiration dating of either three months or nine months. Stability data shows that at three months, room temperature storage, heparin potency drops from 100% to 0.0%.

_______ UPDATE Sterile devices and non-sterile device packs/kits, Recall #Z-156-9 (Associated Hospital Services, Inc., New Orleans, Louisiana), which appeared in the December 9, 1998 Enforcement Report is a completed recall.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________ PRODUCT
Lenses, Soft Contact, Extended Wear. Recall #Z-301-9.

CODE
Lot 50017647, EXP 05/2002.

MANFACTURER
Wesley Jessen/pbh Ltd., Southampton, Hampshire, UKSO30 3HB.

RECALLED BY
Wesley-Jessen Corporation, Des Plaines, Illinois, by telephone on December 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
26 3-packs and 78 6-packs were distributed.

REASON
The contact lenses were mislabeled with the wrong power. -2 diopter lenses were labeled as +2 diopters.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

_________ PRODUCT
AgriLabs Calcium Gluconate 23% Solution Sterile-nonpyrogenic labeled as an aid in the treatment of milk fever in cattle, in 500 ml bottles, labeled as product manufactured for Agri Laboratories, Ltd., St. Joseph, MO 64503. Recall #V-027/028-9.

CODE
Lot Number R7D006, Expiration Date 04/99 Lot Number R7E012, Expiration Date 05/99.

MANFACTURER
Radix Laboratories, Inc., Eau Claire, Wisconsin.

RECALLED BY
Manufacturer, by letter on November 2, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
7,072 bottles of lot R7D006 and 7,018 of lot R7E012 were distributed.

REASON
Precipitate found in the injectable parenteral product.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III

________ PRODUCT
TM-50 - 50 lb bags, oxytetracycline, type A medicated article used for increased weight gain and improved feed efficiency and for treatment of bacterial infections. Recall #V-029-9.

CODES
Lots 7-136-6834 and 7-136-6835 EXP 11/98.

MANFACTURER
International Nutrition, Inc., (INI), Omaha, Nebraska.

RECALLED BY
Manufacturer, by telephone on August 10, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Iowa, Nebraska, California.

QUANTITY
8,050 pounds for each lot number were distributed.

REASON
Product failed stability testing. Product was in the 87% range of labeled claims. Product is subpotent.

End of Enforcement Report for DECEMBER 23, 1998.
[FDA HOME PAGE]