November 6, 1996 96-45 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Entenmann's Chocolate Chip Cookies, in 12 ounce boxes. Recall #F-028-7. CODE B1004 HW manufactured on 9/18/96. MANUFACTURER Entenmann's Inc., Miami, Florida. RECALLED BY C.P.C. Baking Business (doing business as Entenmann's, Inc.), Bay shore, New York, by press release and by notifying the Food Allergy Network, on September 24, 1996, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Florida, Georgia, North Carolina, South Carolina, Virginia. QUANTITY 3,732 boxes were distributed. REASON Product contains undeclared walnuts and nonfat dry milk. _______________ PRODUCT Various flavors and varieties of ice cream, in 3 gallon tubs, half gallon and quart size plastic containers: (a) Maple Walnut Ice Cream (b) Butter Pecan Ice Cream (c) Chocolate Peanut Buttercup Ice Cream. Recall #F-029/031-7. CODE All misbranded product. MANUFACTURER M.B.B. Annis Dairy of Avon, Inc., Avon, New York. RECALLED BY Manufacturer, by telephone on September 20, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY (a) 119 3-gallon, 23 half-gallon, 15 quart size containers; (b) 88 3-gallon, 15 half- gallon, 3 quart size containers; (c) 51 3- gallon size containers were distributed. REASON The products bear partial ingredient statements which list the ice cream base ingredients only. The nuts in these products are not listed in the ingredient statement and there is a potential for consumers sensitive to the nuts to think the product is merely flavored and does not contain the actual allergen. Product a) contains walnuts; product b) contains pecans; product c) contains peanuts. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Pastry Dough Shells (Discos), packaged in plastic bags of 10, under the Rico, Delicia, and Goya labels. Recall #F-024-7. CODE None. All misbranded product is under recall. MANUFACTURER Rico Products Company, Paterson, New Jersey, RECALLED BY Manufacturer, by telephone on June 18-19, 1996. Firm-initiated recall complete. DISTRIBUTION New Jersey, New York, Massachusetts, Connecticut, Pennsylvania, District of Columbia. QUANTITY Firm estimates none remains on the market. REASON Product contains undeclared FD&C Yellow No. 5. _______________ PRODUCT Goya Cola Champagne, in 355 ml (12 fluid ounce) glass bottles. Recall #F-025-7. CODE Lot number 20895. MANUFACTURER The Lion Brewery, Wilkes-Barre, Pennsylvania. RECALLED BY Goya Foods, Inc., Secaucus, New Jersey, by telephone on June 21-25, 1996. Completed recall resulted from sample analysis and follow up by the New York State Department of Agriculture Markets. DISTRIBUTION New Jersey, Massachusetts. QUANTITY Approximately 2,020 cases were distributed; firm estimates none remains on the market. REASON Product contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. -2-_______________ PRODUCT Tofutti brand Non Dairy Original Premium Frozen Dessert, Chocolate Cookie Crunch Flavor, in 1-pint containers. Recall #F-027-7. CODE 42097-42698 and 42097-62698. MANUFACTURER Kemps Foods, Inc., Lancaster, Pennsylvania. RECALLED BY Tofutti Brands, Inc., Cranford, New Jersey, by telephone followed by letter dated July 23, 1996, and by press release dated June 19, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 2,880 units were distributed; firm estimates none remains on the market. REASON Product contained undeclared almonds. _______________ PRODUCT Various flavors and varieties of ice cream, in 3 gallon tubs, half gallon and quart size plastic containers: (a) Toffee Bar Krunch Ice Cream (b) Chocolate Almond Ice Cream (c) Pistachio Almond Ice Cream (d) Bubble Gum Ice Cream. Recall #F-032/035-7. CODE All misbranded product. MANUFACTURER M.B.B. Annis Dairy of Avon, Inc., Avon, New York. RECALLED BY Manufacturer, by telephone on September 20, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY (a) 58 3-gallon, 6 half-gallon; (b) 214 3- gallon, 17 half-gallon, 10 quart size containers; (c) 69 3-gallon, 8 half-gallon size containers; (d) 65 3-gallon, 1 half- gallon size containers were distributed. REASON The products bear partial ingredient statements which list the ice cream base ingredients only. The nuts or color additive in these products are not listed in the ingredient statement and there is a potential for consumers sensitive to the nuts to think the product is merely flavored and does not contain the actual allergen. Products (a), (b), and (c) contain almonds; and product (d) contains FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Minute Maid Premium Calcium-Rich Orange Juice, in 64 ounce gable-top cartons. Recall #F-026-7. -3-CODE Lot Number: Container: OCT22PWY XXX CT349 Y= A,B or Filler XXXX= Time Shipping Case: OCT22T33407B. MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan. RECALLED BY Coca-Cola Foods, Houston, Texas, by telephone on August 30, 1996. Firm-initiated recall complete. DISTRIBUTION Wisconsin, Michigan, Pennsylvania, Iowa, Illinois, Kentucky, Ohio, Minnesota, Nebraska, Indiana, Missouri. QUANTITY 4,425 cases were distributed. REASON Product is contaminated with yeast. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Sulfatrim Pediatric Suspension (Sulfamethoxazole and Trimethoprim, USP), in one pint bottles, used for the treatment of urinary infections due to susceptible organism strains, for the treatment of acute otitis media in children due to susceptible strains of streptococcus pneumoniae or haemophilus influenzae, under the Barre-National and Schein Pharmaceutical labels. Recall #D-027-7. CODE Lot #RJ4459 0364-2077-16. MANUFACTURER Alpharma, U.S. Pharmaceuticals Divisions, also known as Barre-National, Inc., Baltimore, Maryland. RECALLED BY Manufacturer, by letter on or about June 3, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 3,948 Schein labeled product was distributed. REASON Some units may appear brown in color with a licorice flavor instead of red and cherry- flavored. Taste/color change may be caused by degradation. _______________ PRODUCT Glaxo Wellcome brand (a) Zovirax Sterile Powder for Injection (Acyclovir Sodium), 1000 mg/vial, in 20 ml vials, used in the treatment of herpes; (b) Mivacron Injection (Mivacurium Chloride), in 2 mg/ml, 20 ml multi-dose vials for IV administration, a non-depolarizing skeletal muscle relaxant. Recall #D-029/030-7. -4-CODE Lot numbers: (a) 5W3017, 5W3018, 5X3021. A portion of lot 5W3017 was packaged and distributed in Canada as lot #5K190; (b) Lot numbers: 5S3014, 602362, 6S1819. A portion of lot #602362 was packaged and distributed in Canada as lot #6E592. MANUFACTURER Glaxo Wellcome, Inc., Research Triangle Park, North Carolina. RECALLED BY Manufacturer, by letter delivered during the week of October 21, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY (a) Lot 5W3017 - 23,470 vials in the U.S. and 12,107 vials in Canada; estimate none remains on the market; 25,240 vials of lot 5W3018 in the U.S., estimate none remains on the market. There were 35,520 vials of lot 5X3021 distributed in the U.S., firm estimates 15,000 remain on the market; (b) Lot 5S3014 -- 44,810 vials were distributed in the U.S. and estimate none to be on the market; 25,900 vials of lot 6O2362 were distributed in the U.S. and 4,800 in Canada, firm estimate 13,000 vials to be on the market in the U.S. and 1,000 on the market in Canada; 54,160 vials of lot 6S1819 distributed in the U.S., with an estimated 11,000 vials still on the market. REASON (a) Defects in the glass vials may result in product contamination and/or problems with reconstitution; (b) Defects in the glass may result in product contamination. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Imipramine Hydrochloride Tablets, USP, 10 mg, in bottles of 100 and 1000, Rx for the relief of symptoms of depression, under the following labels: Par Pharmaceutical, United Research Laboratories, Martec Pharmaceutical, Parmed Pharmaceutical. Recall #D-028-7. CODE control number C28494, EXP 9/96. MANUFACTURER Par Pharmaceutical, Inc., Spring Valley, New York. RECALLED BY Manufacturer, by letter on July 11, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 1,250 bottles of 100 and 279 bottles of 1000 tablets were distributed; firm estimated that little or no product remained on market at time of recall initiation. -5-REASON Product is not stable: This lot failed dissolution test (72%; Spec is NLT 75%) at the 12-month stability timepoint. _______________ PRODUCT Purepac Pharmaceutical brand Metoprolol Tartrate Tablets, USP 50 mg, in bottles of 1000, Rx indicated for the treatment of hypertension and angina. Recall #D-031-7. CODE Lot #187A6 EXP 2/98. MANUFACTURER Faulding Pharmaceutical Company (Purepac Pharmaceutical Co.), Elizabeth, New Jersey. RECALLED BY Manufacturer, by letter on July 19, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,128 bottles were distributed; firm estimated that 980 bottles remained on market at time of recall initiation. REASON Some tablets may be overweight and superpotent. _______________ PRODUCT Cimetidine Tablets, USP, 800 mg; an oral Rx drug used in the treatment of ulcers, erosive gastroesophageal reflux disease, and the treatment of pathological hypersecretory conditions; packaged under the following labels and package sizes: (a) Novopharm, manufactured for: Novopharm USA, Schaumburg, IL, in 500 tablet bottles, (b) H.L. Moore, distributed by: H.L. Moore Drug Exchange, New Britain, Conn., in 100 tablet bottles (c) W/C Warner Chilcott, manufactured for Warner Chilcott Labs, Div. of Warner-Lambert Co., Morris Plains, NJ USA, in 100 tablet bottles (d) Schein Pharmaceutical Inc., manufactured for Schein Pharmaceutical, Inc., Florham Park, NJ 07932 USA, in 100 tablet bottles (e) Martec Pharmaceutical Inc.; manufactured for Martec Pharmaceutical, Inc., Kansas City, MO in 100 tablet bottles (f) GG, distributed by Geneva Pharmaceuticals, Inc., Broomfield, CO, in 100 tablet bottles, (g) Warrick Pharmaceuticals, Manufactured by: Novopharm Ltd., Toronto, Canada, Warrick Pharmaceuticals Corporation, Niles, Illinois, in 100, 500, and 1000 tablet bottles. Recall #D-032-7. -6- CODE Lot 55476 EXP 1/97. Note: The lot number has various suffixes, dependent on the bottle size, i.e. 55476A, 55476B, 5547640, 5547670, and 5547680. MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated October 18, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,010 bottles of 100 tablets, 698 bottles of 500 tablets and 265 bottles of 1000 tablets were distributed, with the firm estimating that very little, if any, remains on the market. REASON Lot failed dissolution test at the 18-month stability timepoint. _______________ PRODUCT Parke-Davis brand Phenelzine Sulfate Tablets, USP Nardil, 15 mg, in bottles of 100, Rx used in the treatment of depression. Recall #D-033-7. CODE Lot #07425D. MANUFACTURER The Park-Davis Division of Warner-Lambert Company, Morris Plains, New Jersey. RECALLED BY Manufacturer, by letter on June 17, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 18,432 bottles were distributed. REASON Lot failed content assay (subpotent) at the 12-month stability timepoint. _______________ PRODUCT Parke-Davis brand Procanbid, Procainamide HCl Extended Release Tablets, 1000 mg, Rx, in bottles of 60, indicated for the treatment of documented ventricular arrhythmias. Recall #D-034-7. CODE Lot #788N5D EXP 8/98. MANUFACTURER The Parke-Davis Division of Warner-Lambert Company, Morris Plains, New Jersey. RECALLED BY Manufacturer, by letter on June 18, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,747 bottles were distributed; firm estimates none remains on the market. REASON Lot failed dissolution test (low at the 8-hour interval) at the 3-month stability timepoint. -7-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I ======== _______________ PRODUCT Albuminar Albumin (Human), U.S.P, (a) Albuminar - 25 (Albumin 25%, Human, USP); (b) Albuminar - 5 (Albumin 5%, Human, USP). Recall #B-001/002-7. CODE (a) 25% 50 ml - lot P61205 EXP 12 MAY 99, M60902 EXP 09 FEB 97, M54512 EXP 02 DEC 97; 100 ml - lot L58211 EXP 12 NOV 96, M61403 EXP 28 FEB 97, M63204 EXP 14 APR 97, M54912 EXP 05 DEC 97, P61805, EXP 22 MAY 99. (b) 5% 50 ml - lot P18607 EXP 26 JUN 99 500 ml - lot L8212 EXP 20 DEC 96. MANUFACTURER Centeon L.L.C., Kankakee Industrial Operations, Kankakee, Illinois. RECALLED BY Centeon L.L.C., King of Prussia, Pennsylvania, by telephone on September 20 and 23, 1996, followed by letter. Firm-initiated recall ongoing. See also FDA talk papers T96-65, October 3, 1996, and T96-69, October 9, 1996. DISTRIBUTION Nationwide and international. QUANTITY 18,508 50-ml vials and 1,677 500-ml vials of 5%, and 52,759 50-ml vials and 42,957 100-ml vials of 25% were distributed. The firm estimates that 18,000 vials remained on market at time of recall initiation. REASON Biological products which either tested positive for Enterobacter cloacae and is associated with cases of septicemia or the vials may have been damaged during product handling possibly resulting in cracked vials. Cracked vials have the potential for microbial contamination. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall #B-032/033-7. CODE Unit #KC34846. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on February 8, 1996. March 12, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot indeterminate, and RIPA reactive. -8-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Recovered Plasma. Recall #B-034-7. CODE Unit #KC34846. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by fax on March 12, 1996. Firm- initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot indeterminate, and RIPA reactive. _______________ PRODUCT Red Blood Cells. Recall #B-035-7. CODE Unit numbers: 4435375 and 4435381. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter dated July 12, 1995. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 2 units were distributed. REASON Blood products were collected from donors for which donor suitability was not adequately determined. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Surgitek and Microvasive brand Gastrostomy feeding tube kits: (a) (Surgitek) Surgi-Peg Initial Placement Gastrostomy Tray, Pull System, 15 FR size; (b) Surgi-Peg Replacement Gastrostomy Device, 15 FR size; and the Microvasive brand, Initial Placement Gastrostomy Kit, Pull Method, 15 FR size, and the Microvasive brand, Initial Placement Gastrostomy Kit, Guidewire Method, 15 FR size. Recall #Z-030/031-7. CODE (a) (Surgitek) Surgi-Peg Pull System, Product Code #1101115, Box Lot #9505412, Tray Lot #9562511; (Microvasive) Pull Method, Product Code #6415, Box Lot #9625101 and #957312, Tray Lot #9562611 and #9512512; (Microvasive) Guidewire Method, Product Code #6416, Box Lot #9653901, #9627501, and #9627801, Tray Lot #9560012 and #9557712; (b) Product Code #1102315, Box Lot #9626001, Tray Lot #9523812. -9-MANUFACTURER Applied Medical Technology, Independence, Ohio. RECALLED BY Manufacturer, by letter dated January 24, 1996. Firm-initiated recall complete. DISTRIBUTION Massachusetts and Wisconsin. QUANTITY Firm estimates none remains on the market. REASON The bolsters used for these kits had been punched with 20FR holes rather than the correct 15FR holes. _______________ PRODUCT Surgitek brand Surgi-Peg Initial Placement Gastrostomy Tray - Pull System, 15 FR size, gastrostomy feeding tube kits. Recall #Z-032-7. CODE Product #1101115, box lot #9520108, tray lot #9530307. MANUFACTURER Applied Medical Technology, Independence, Ohio. RECALLED BY Manufacturer, by letter dated October 5, 1995, and by telephone on September 30, 1996. Firm- initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY Firm estimates none remains on the market. REASON The bolsters used for these kits had been punched with 20FR holes rather than the correct 15FR holes. _______________ PRODUCT Signature Edition Infusion Pumps, Models 7100 and 7200. Recall #Z-034/035-7. CODE All pumps. MANUFACTURER Ivac Medical Systems, Inc. San Diego, California. RECALLED BY Manufacturer, by recall notification dated August 8, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 4,069 units were distributed. REASON A defective pressure sensing system causes the pump to alarm and shutdown, and in some situations not restart until the instrument is serviced. _______________ PRODUCT Sterile Gauze Sponges, 4" x 4", Reorder #4482. Recall #Z-057-7. CODE Lot #1407122. MANUFACTURER China National Medicines & Health Products Import & Export Corporation, Yangzhou, China. RECALLED BY Dav-Mar Medical Products, Inc. (D.M.M.P.), Yonkers, New York, by letter dated September 17, 1996. Firm-initiated recall ongoing. -10-DISTRIBUTION New York, New Jersey, Connecticut. QUANTITY 1,355 cases were distributed; firm estimates none remains on the market. REASON Sponges were found to be non-sterile by FDA analysis. _______________ PRODUCT Newport Breeze Ventilator, Model #E150. Recall #Z-058-7. CODE Serial numbers 8908BR021J through 8908BR021J and 8903BR001 through 9103JB100. MANUFACTURER Newport Medical Instruments, Inc., Costa Mesa, California. RECALLED BY Manufacturer, by letter June 28, 1991. Firm- initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 752 units were distributed. REASON The diaphragm on the spontaneous flow valve may rupture or leak, possibly resulting in hypoxemia to the patient. _______________ PRODUCT Sphygmomanometer, blood pressure meter. Recall #Z-060-7. CODE All lots shipped to Ciba-Geigy, Summit, NJ on or about August 1995. MANUFACTURER Kam Ma Trading Company, a subsidiary of Golden Pacific Industrial Ltd., Tsuen Wan, Hong Kong. RECALLED BY BHS International, Crofton, Maryland (importer), by letter dated September 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 27,000 units were distributed. REAS0N The device was being marketed without a cleared premarket notification submission under section 510(k) of the Act. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT BacT/View Software Version A.00, distributed as a part of the BacT/VIEW Manual/Software Assemblies, Part numbers 22105-16 and 22111-4, used with Organon Teknika's BacT/Alert and MB/Bact Microbial Detection Systems' data management system. Recall #Z-038-7. CODE All units. MANUFACTURER Organon Teknika, Oklahoma, City, Oklahoma. RECALLED BY Manufacturer, by issuing a "Technical Bullet" dated September 5, 1996, and by letter September 13, 1996. Firm-initiated field correction complete. -11-DISTRIBUTION Nationwide. QUANTITY 34 domestic BacT/Alert and MB/AacT units had been upgraded with BacT/VIEW A.00 software. REASON The computerized data bases of BacT/Alert and MB/BacT Microbiological Detection Systems running BacT/VIEW software may become corrupted and the system may stop reporting sample results. _______________ PRODUCT Total Bilirubin Test Kit, for the quantitative determination of total bilirubin in serum. Recall #Z-039-7. CODE Lot numbers: 60941 EXP 4/98 and 61441 EXP 5/98. MANUFACTURER Horizon Diagnostics, Inc., Ann Arbor, Michigan. RECALLED BY Manufacturer, by letter dated September 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,135 kits were distributed. REASON Product may not contain a validated standard at the concentration stated on the label, which could yield inaccurate results. _______________ PRODUCT LuMax Cystometry System with Uroflow and Volume Infused Options, used to measure pressures in the bladder, abdomen, and urethra for the diagnosis of urinary incontinence, bladder outflow obstruction, and other bladder disorders. Recall #Z-052-7. CODE Only units with the volume infused transducer option are affected. MANUFACTURER MedAmicus, Inc., Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter on October 7, 1996. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Colorado, Florida, Georgia, Maryland, North Carolina, New York, Pennsylvania, Tennessee, Texas, Utah, West Virginia. QUANTITY 23 units were distributed. REASON The amount of liquid infused into the bladder to perform tests may be recorded erroneously high. _______________ PRODUCT CLOTrac RACT Abnormal Coagulation Control, used to confirm the performance of Automated Coagulation Timers, or other versions and methodologies for performing a recalcified activated clotting time test. Recall #Z-055-7. -12-CODE Lot #9608000094. MANUFACTURER Medtronic Blood Management, Parker, Colorado. RECALLED BY Manufacturer, by letter on September 23, 1996, followed by telephone on September 26-27, 1996. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Iowa, Michigan, Mississippi, New York, Texas, Washington state. QUANTITY 36 boxes (540 units) were distributed. REASON The clotting range listed in the package insert for this lot number is higher than the actual clotting range for this control. Use of this control will indicate that the device is out of calibration. _______________ PRODUCT Herpes Simplex Virus (HSV)-CF Antigen. Recall #Z-056-7. CODE Catalog #CF-02-05, Lot numbers 02009A and 02011E1. MANUFACTURER Microbix Biosystems, Inc., Toronto, Ontario, Canada. RECALLED BY Manufacturer, by letter followed by telephone on August 22, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 11 vials. REASON Testing revealed a potential loss of stability. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ==== _______________ PRODUCT Cyanamid Aureomycin Sulmet Soluble Powder (chlortetracycline HCl and sulfamethazine bisulfate), in 4 ounce pouches, antibacterial for oral veterinary use in swine only.. Recall #V-018-7. CODE Lot #950780 EXP 5/99. MANUFACTURER PM Resources, Inc., Bridgeton, Missouri. RECALLED BY American Cyanamid Company, Fort Dodge, Iowa, by letter on September 17, 1996. Firm- initiated recall complete. DISTRIBUTION Indiana, Iowa, Missouri, Nebraska, North Carolina, Wisconsin. QUANTITY 279 40-pouch pails were distributed. REASON Sulfamethazine levels were below specifications at 12 months stability. Low sulfamethazine potency was attributed to low formulation by the manufacturer. #### END OF ENFORCEMENT REPORT FOR NOVEMBER 6, 1996. BLANK PAGES MAY FOLLOW. -13-End of Enforcement Report for