April 9, 1997 97-15 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT (a) Transfilled Medical Oxygen in D, E, J, MPs and K cylinders; (b) Liquid Medical Oxygen. Recall #D-132/133-7. CODE All codes, all lots, and all fill dates. MANUFACTURER Lewin Agency, Inc., doing business as Lewin Medical Supply, Riverhead, New York. RECALLED BY Manufacturer, by telephone on March 18, 1997, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 132 cylinders and 2 31-liter cryogenic vessels were distributed. REASON Current good manufacturing practice deficiencies (FDA inspection found that product was not tested for strength and the oxygen analyzer was not properly maintained). _______________ PRODUCT Clindamycin Phosphate Injection, USP, 150 mg/ml, Rx small volume parenteral semisynthetic antibiotic for IV or IM administration for the treatment of serious infections caused by susceptible anaerobic bacteria; packaged in 2 ml, 4 ml and 6 ml single dose vials, 25 vials per box. Recall #D-137-7.CODE Catalog 22602, 2 ml fill in 2 ml vial, Catalog 22604, 4 ml fill in 5 ml vial, Catalog 22606, 6 ml fill in 10 ml vial. Lot numbers 951067, 951069, 951222, 951235, 960639, 951040, 951084, 951146, 960126, 960618 MANUFACTURER SoloPak Pharmaceuticals Inc., Elk Grove Village, Illinois. RECALLED BY Manufacturer, by letter dated March 13, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 320,000 vials were distributed; firm estimated that 1 percent of product remained on market at time of recall initiation. REASON Bulk Clindamycin was recalled by Roussel Corporation (parent firm of Biochimica Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. _______________ PRODUCT Clindamycin Phosphate Injection, USP sterile solution (150mg/ml) in 2ml, 4ml, 6ml, and 60ml single dose containers (SDC) which are packaged 25 SDCs per intermediate carton, a prescription drug given intramuscularly or intravenously for the treatment of serious infections caused by susceptible anaerobic bacteria. Recall #D-138-7. CODE (2ml) Lot Nos. 1450605038, 1450608035. (4ml) Lot Nos. 1451509066, 1451601040, 1451603105, 1451605035, 1451606048, 1451609805, and 1451609806. (6ml) Lot Nos. 1452509065, 1452603109, 1452605033, 1452606051, and 1452609804. Lot Nos. 1453510021, 1453601100 and 1453610040. MANUFACTURER Astra USA Inc. Westboro, Massachusetts. RECALLED BY Manufacturer, by letter dated March 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 47,757 saleable units were distributed; firm estimated that 3,100 units of product shipped prior to January 31, 1997, were still in distribution at time of recall initiation. REASON Bulk Clindamycin was recalled by Roussel Corporation (parent firm of Biochmicia Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. _______________ PRODUCT Phenytoin Oral Suspension, USP packaged in unit dose cups and oral syringes, Rx oral antiepileptic drug, unit dose cups are packaged 10 cups per tray, with 5 or 10 trays -2- per case, 100 mg 4-ml unit dose cup, 50 cups/case; 100 mg 4-ml unit dose cup, 100 cups/case; 100 mg 4-ml oral syringe, 50 syringes/case; 300 mg 12-ml unit dose cup, 100 cups/case. Recall #D-140-7. CODE All lots within expiration date -- 605609, 604610, 603614, 603613, 603601, 602802, 602606, 602605, 601612, 601614, 512609, 512604, 512606, 512607, 512603, 511606, 511605, 510604, 510606, 510607, 509612, 509607, 509606, 509612. MANUFACTURER Parke-Davis, Division of Warner-Lambert Company, Morris Plains, New Jersey. RECALLED BY Xactdose, Inc., South Beloit, Illinois (repacker), by letter dated March 4, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 6,116 cases of 50/4 ml cups, 15,372 cases of 100/4 ml cups, 174 cases of 100/12 ml cups, and 116 cases of 50/4 ml oral syringes were distributed; firm estimates that little, if any, product remains on the market. REASON Product failed content uniformity test. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Dexamethasone Sodium Phosphate for Injection, USP, 10 mg/ml, in 10 ml multi-dose vials, sterile, injectable glucocorticoid, under the following labels: Steris, Schein, Clint, and Robar. Recall #D-136-7. CODE LOT EXPIRATION 95E710 7/97 95F530 9/97 95K460 11/97 95L190 11/97 95L770 12/97 96C420 3/98 96H430 7/98. MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter dated January 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Peru. QUANTITY Approximately 94,500 vials were distributed. REASON Product failed pH specification (SPEC is 7.0- 8.5pH); actual is 8.6. _______________ PRODUCT Trisoralen Tablets, 5 mg. (Trioxsalen, USP), packaged in bottles of 28 tablets and 100 tablets, (bottles of 10 and 1000 were -3- exported), a prescription drug for oral administration and is indicated for the repigmentation of idiopathic vitiligo; for increasing tolerance to sunlight and for enhancing pigmentation. Recall #D-139-7. CODE All lot numbers (18 total) within expiration date are under recall. The lot numbers and expiration dates which identify domestic, and possibly, foreign distribution are: E0216 (2/97), E0503 (5/97), E1107 (11/97), E1124 (12/97), F0102 (2/98), F0219 (3/98), F0408A (5/98), F0408B (5/98), F1217B (1/99), F1217B (1/99), G0816A (9/99), G0816B (9/99), G1001A (11/99), G1001B (11/99), H0321A (5/00), H312B (5/00), H0831A (9/98), H1122B (12/98). The lot numbers which exclusively identify international distribution are: E1228, F0403A, F0403B, F0219E, F0408AE, F0408BE, F0801A, F0801B, H0831B, & H1122A. MANUFACTURER ICN Pharmaceuticals, Inc., Inc., Costa Mesa, California (responsible firm). RECALLED BY ICN Pharmaceuticals, Inc., Bryan, Ohio, by letter dated February 25, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 58,514 bottles were shipped to domestic accounts. REASON Product fails dissolution test requirements (SPEC is NLT 75%; actual is as low as 45%). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-507-7. CODE Unit #12LP09541. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 8, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but was collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. -4-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-530/531-7. CODE Unit numbers: (a) 25GX16989, 25GX24532; (b) 25GX16989. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated June 28, 1996. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY (a) 2 units; (b) 1 unit was distributed. REASON Blood products were collected from a donor who reported a history of intravenous (IV) drug use. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-533/534-7. CODE Unit #26146-9450. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 16, 1996. Firm-initiated recall complete. DISTRIBUTION Arkansas and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products confirmed positive for syphilis. _______________ PRODUCT Red Blood Cells. Recall #B-536-7. CODE Unit #53H38588. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 31, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-537-7. CODE Unit #53LN09463. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 31, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area considered endemic for malaria. -5-_______________ PRODUCT Red Blood Cells. Recall B-538-7. CODE Unit numbers: 25GE31781, 25GE33113, 01GX00010. MANUFACTURER American Red Cross Blood Services, Schenectady, New York. RECALLED BY Manufacturer, by letters dated November 21 or 25, 1996. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT (a) Platelets; (b) Fresh Frozen Plasma. Recall #B-540/541-7. CODE Unit #13L80117. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated October 17, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products corresponding to Red Blood Cells were returned because of confirmed clots present in the bag segments. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-542/544-7. CODE Unit numbers: (a) 16LC00616, 16LC01290; (b) 16LC00616; (c) 16LC00616, 16LC01290. MANUFACTURER American Red Cross, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated November 20, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units were distributed. REASON Blood products were collected from a donor currently taking the drug Imuran. _______________ PRODUCT Various allergenic extracts: (a) Standardized Allergenic Extract Mite Dermatophagoides pteronyssinus, 30,000 AU/Ml (b) Standardized Allergenic Extract Mite Dermatophagoides pteronyssinus Intradermal Test (c) Standardized Allergenic Extract Mite Mixture (Dermatophagoides farinae and Dermatophagoides pteronyssinus 15,000 AU/Ml. Recall #B-546/548-7. -6-CODE Lot numbers: (a) J76D1321, 10 ml, EXP 10/01/98; J76B2719, 30 ml, EXP 10/01/98; J76B2724, 30 ml, EXP 10/01/98 (b) C66C5638, 30 AU/ml, 5 ml, EXP 3/01/97; C66C56636, 300 AU/ml, 5 ml, EXP /01/97 (c) J75L6368, 30 ml, EXP 10/01/98. MANUFACTURER Bayer Corporation Pharmaceutical Division Allergy Products, Spokane, Washington. RECALLED BY Manufacturer, by letter on February 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 558 vials were distributed. REASON Product contains a percentage of Dermatophagoides farinae not listed on the product labeling. _______________ PRODUCT Platelets, Pheresis. Recall #B-550-7. CODE Unit #7138971. MANUFACTURER Oklahoma Blood Institute, Enid, Oklahoma. RECALLED BY Manufacturer, by fax on January 25, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-553/554-7. CODE Unit #10001251. MANUFACTURER Stewart Regional Blood Center, Tyler, Texas. RECALLED BY Manufacturer, by letter dated February 13, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of intravenous (IV) drug use. _______________ PRODUCT Red Blood Cells. Recall #B-556-7. CODE Unit #2410898. MANUFACTURER Carter Blood Center, Fort Worth, Texas. RECALLED BY Manufacturer, by telephone on February 5, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product tested positive For CMV antibody was labeled as negative. -7-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Red Blood Cells. Recall #B-529-7. CODE Unit numbers: 7002639, 7002640, 8048513, 8048514, 8050645, 8050835, 8957098, 8957100, 8959172, 8959290, 8959328, 8961602, 8961688, 8961736, 8963668, 8964467, 8969627, 8970015, 8971367, 8972928 . MANUFACTURER West Tennessee Regional Blood Center, Inc., doing business as Lifeline Blood Services, Jackson, Tennessee. RECALLED BY Manufacturer, by telephone between April 11 and 22, 1996. Firm-initiated recall complete. DISTRIBUTION Tennessee and Massachusetts. QUANTITY 20 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-532-7. CODE Unit #26147-0791. MANUFACTURER United Blood Services, Fort Smith Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 16, 1996. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product may have remained at room temperature for an unacceptable length of time. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-535-7. CODE Unit #26147-2256. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 22, 1996. Firm- initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood designated as a difficult collection. _______________ PRODUCT Red Blood Cells. Recall #B-539-7. CODE Unit #C 65576. MANUFACTURER Regional Health Resources Center, Community Blood Services of Illinois, Urbana, Illinois. -8-RECALLED BY Manufacturer, by telephone on July 28, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product developed small clots in the bag during the collection process thus preventing the transfusion of the entire unit. _______________ PRODUCT Red Blood Cells. Recall #B-545-7. CODE Unit #KE59945. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on December 5, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who confidentially excluded the unit. _______________ PRODUCT Abbott HTLV-1 2.0 EIA Diagnostic Kit Human T- Lymphtropic Virus Type I. Recall #B-549-7. CODE Lot #2137M301, 21307M302 EXP 3-31-97. MANUFACTURER Abbott Laboratories, Diagnostic Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone on March 10, 1997, followed by letter. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 202 kits were distributed REASON Reconstituted HTLV-I 2.0 EIA Conjugate does not consistently meet the Positive Control validity requirement. _______________ PRODUCT Recovered Plasma. Recall #B-552-7. CODE Unit #21FJ04987. MANUFACTURER American Red Cross Blood Services, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by fax on February 3, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. _______________ PRODUCT Gamma Reagent Red Blood Cells, 3-4%, for antibody detection: (a) Duet Reagent Red Blood Cells (b) Trio 1, 2, and 3 Reagent Red Blood Cells -9- (d) Panel One Reagent Red Blood Cells (e) Panel Two Reagent Red Blood Cells (f) Panel 15 Reagent Red Blood Cells (g) Panel 20 Reagent Red Blood Cells. Recall #B-555-7. CODE Lot numbers: (a) 1126\1 (Cell I), 1126/2 (Cell I), 1126/3 (Cell II), 1126/5 (Cell I & II), 1126/6 (Cell I), 1126/7 (Cell I), 1203/8 (Cell I); (b) 1126/1 (Cell 3), 1126/3 (Cells 1 & 3), 1126/5 (Cell 2), 1126/6 (Cells 1 & 3), 1203/1 (Cells 1 & 3), 1203/2 (Cell 1); (c) 1203 (Cells 1, 2, & 10); (d) 1126 (Cells 3, 7, & 10); (e) 1126/15 (Cells 3 & 14); (f) 1210/20 (Cell 16). MANUFACTURER Gamma Biologicals, Inc., Houston, Texas. RECALLED BY Manufacturer, by priority mail and by fax beginning December 16, 1996, and by letter dated January 13, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Firm estimates none remains on the market. Product expired on January 11, 1997. REASON Reagent Red Blood Cells failed to show reactivity with anti-S antibodies. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Premier Cryptosporidium, a rapid in vitro microwell EIA for the qualitative detection of Cryptosporidium oocyst antigen in stool. Recall #Z-379-7. CODE Catalog No. 601196, Lot Nos. 601196.002 and 601196.003. MANUFACTURER L.M.D. Laboratories, Inc., Carlsbad, California. RECALLED BY Meridian Diagnostics, Inc., Cincinnati, Ohio, by letter on February 14, 1997. Firm- initiated recall complete. DISTRIBUTION Nationwide, Italy, New Zealand. QUANTITY 61 kits were distributed. REASON The package insert and procedure card contain an error in that they state the absorbance of the samples is to be determined spectrophotometrically at a single wavelength. However, correct procedure is to determine the absorbance at dual wavelengths. -10-_______________ PRODUCT Premier Giardia Lamblia, a rapid in vitro microwell EIA for the qualitative detection of Giardia lamblia trophozoite and cyst antigen in stool. Recall #Z-380-7. CODE Catalog #609096, Lot numbers 609096.040 and 609096.041. MANUFACTURER L.M.D. Laboratories, Inc., Carlsbad, California. RECALLED BY Meridian Diagnostics, Inc., Cincinnati, Ohio, by letters dated February 12 and 19, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide, Italy, New Zealand. QUANTITY 177 kits were distributed. REASON Product was manufactured so that the absorbance of samples is to be determined spectrophotometrically at dual wavelengths. However, the correct procedure, as stated in the labeling, is to determine the absorbance at a single wavelength. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Chocolate Agar with Enrichment, Catalog No. P1250, in-vitro diagnostic device. Recall #Z-381-7. CODE Lot No. 051409. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on May 23, 1996. Firm-initiated recall complete. DISTRIBUTION Hawaii. QUANTITY 100 plates were distributed. REASON Product was contaminated with bacteria. _______________ PRODUCT Inhibitory Mold Agar, in-vitro diagnostic device. Recall #Z-382-7. CODE Catalog No. P1725, Lot No. 042922. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on May 23, 1996. Firm-initiated recall complete. DISTRIBUTION Hawaii and Washington state. QUANTITY 30 plates were distributed. REASON Product was contaminated with fungus. _______________ PRODUCT Sabourand Dextrose with Gentamacin, in-vitro diagnostic device. Recall #Z-383-7. CODE Catalog No. P2307, Lot No. 040917. -11-MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on May, 13, 1996. Firm-initiated recall complete. DISTRIBUTION New York, Connecticut, Canada. QUANTITY 60 plates were distributed. REASON Product was contaminated with fungus. _______________ PRODUCT Dnase Test Agar, In-vitro diagnostic device. Recall #Z-384-7. CODE Catalog No. P1552. Lot No. 032606. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on May 8, 1996. Firm- initiated recall complete. DISTRIBUTION Canada. QUANTITY 170 plates were distributed. REASON Product was contaminated with bacteria. _______________ PRODUCT BHI Broth + 5% Fildes, in-vitro diagnostic device. Recall #Z-385-7. CODE Catalog No. T6239, Lot No. 030612T. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on April 30, 1996. Firm-initiated recall complete. DISTRIBUTION Canada. QUANTITY 610 tubes were distributed. REASON Product had contamination in bottom of tube. _______________ PRODUCT Horse Blood Agar Selective, in-vitro diagnostic device. Recall #Z-386-7. CODE Catalog No. P1705, Lot No. 013020. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on February 6, 1996. Firm-initiated recall complete. DISTRIBUTION Montana. QUANTITY 70 plates were distributed. REASON Product was contaminated with bacteria. _______________ PRODUCT Catalase Test Reagent, in-vitro diagnostic device: (a) Catalog No. R6450; (b) Catalog No. R6452. Recall #Z-387/388-7. CODE Lot Numbers: (a) 071902A; (b) 017902A. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on September 14, 1995. Firm-initiated recall complete. -12-DISTRIBUTION Massachusetts and Canada. QUANTITY 2 bottles were distributed. REASON Product was contaminated with excess gas. _______________ PRODUCT Gardenerella Agar, in-vitro diagnostic device. Recall #Z-389-7. CODE Catalog No. P1675, Lot No. 122811. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on January 4, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Wyoming. QUANTITY 80 plates were distributed. REASON Product was contaminated with excess gas. _______________ PRODUCT Tryptic Soy Yeast (TSYA) + 5% Rabbit Blood, in-vitro diagnostic. Recall #Z-390-7. CODE Catalog No. P2560, Lot No. 122024. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by discarding product on January 4, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 160 plates were distributed. REASON Product was contaminated with bacteria. _______________ PRODUCT Martin Lewis Medium Modified Pill Pocket, in- vitro diagnostic device. Recall #Z-391-7. CODE Catalog No. P3602, Lot No. 112938 EXP 2/7/96. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by discarding remaining stock on January 3, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Canada. QUANTITY 1,730 plates were distributed. REASON Product was contaminated with fungus. _______________ PRODUCT Cryptosporidium QC Slides, in-vitro diagnostic device. Recall #Z-392-7. CODE Catalog No. C1200, Lot No. 10170CA EXP 10/18/96 MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on October 31, 1995. Firm-initiated recall complete. DISTRIBUTION Canada. QUANTITY 1 box was distributed. REASON Device had a low number of organisms. -13-_______________ PRODUCT Haemophilus ID Quad, in-vitro diagnostic device. Recall #Z-393-7. CODE Catalog No. P3640, Lot No. 101044 EXP 11/21/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by discarding remaining inventory on October 13, 1997. Firm- initiated recall complete. DISTRIBUTION Oregon, Washington state, Idaho, Canada. QUANTITY 155 plates were distributed. REASON The blood section of the quad is marbled with agar flecks making it difficult to determine hemolysis. _______________ PRODUCT Martin Lewis Medium, in-vitro diagnostic device. Recall #Z-394-7. CODE Catalog No. P3600, Lot No. 092636 EXP 12/19/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, on October 16, 1995. Firm- initiated recall complete. DISTRIBUTION Oregon, California, Canada. QUANTITY 280 plates were distributed. REASON Device was contaminated with mold. _______________ PRODUCT Buffered Charcoal Yeast Extract Agar, in-vitro diagnostic device. Recall Z-395-7. CODE Catalog No. P1250, Lot No. 092508 EXP 11/20/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, on May 23, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state and Canada. QUANTITY 45 plates were distributed. REASON No growth of Legionella due to a lack of growth supplement. _______________ PRODUCT Entero HLAR Agar Quad, in-vitro diagnostic. Recall #Z-396-7. CODE Catalog No. P3630, Lot No. 092217 EXP 10/27/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on September 27, 1995. Firm-initiated recall complete. DISTRIBUTION Hawaii. -14-QUANTITY 20 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT Sabouraud Dextrose Agar, in-vitro diagnostic device. Recall #Z-397-7. CODE Catalog No. P2304, Lot. No. 091117 EXP 11/20/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on September 14, 1995. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 50 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT Sheep Blood/Chocolate Agar with Enrichment, in-vitro diagnostic device. Recall #Z-398-7. Catalog No. P4400, Lot No. 090736 EXP 11/16/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on September 14, 1995. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Idaho. QUANTITY 230 plates were distributed. REASON Device was contaminated with bacteria. _______________ PRODUCT Martin Lewis Medium Modified, in-vitro diagnostic device. Recall #Z-399-7. CODE Catalog No. P3600, Lot No. 082962 EXP 11/21/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on October 6, 1995. Firm-initiated recall complete. DISTRIBUTION Oregon, Virginia, Kentucky, Montana, Canada. QUANTITY 1,500 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT Haemophilus ID Quad, in-vitro diagnostic device. Recall #Z-400-7. CODE Catalog No. P3460, Lot No. 062433 EXP 10/5/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax on September 1, 1995. Firm-initiated recall complete. -15-DISTRIBUTION California. QUANTITY 10 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT Sabouraud Dextrose Agar, in-vitro diagnostic device. Recall #Z-401-7. CODE Catalog No. P2300, Lot No. 082123 EXP 11/27/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on September 15, 1995. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Alaska, Hawaii, Michigan, Canada. QUANTITY 1,150 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT Andrade's Broth - Arabinose, in-vitro diagnostic. Recall #Z-402-7. CODE Catalog No. T6404, Lot No. 081518T EXP 8/14/96. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by telephone on November 30, 1995. Firm-initiated recall complete. DISTRIBUTION California and Canada. QUANTITY 30 tubes were distributed. REASON Device was contaminated with bacteria. _______________ PRODUCT Columbia Agar Base with 5% Sheep Blood/MacConkey Agar, in-vitro diagnostic device. Recall #Z-403-7. CODE Catalog No. P4151, Lot No. 080841-10 EXP 10/3/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on August 31, 1995. Firm-initiated recall complete. DISTRIBUTION Canada. QUANTITY 30 plates were distributed. REASON Device was contaminated with bacteria. _______________ PRODUCT Sabourand Dextrose Agar, in-vitro diagnostic device. Recall #Z-404-7. CODE Catalog No. P2304, Lot No. 081126 EXP 10/20/95. -16-MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on September 11, 1995. Firm-initiated recall complete. DISTRIBUTION California and Canada. QUANTITY 140 plates were distributed. REASON Device was contaminated with bacteria and fungus. _______________ PRODUCT Chocolate Agar with Enrichment, in-vitro diagnostic device. Recall #Z-405-7. CODE Catalog No. P1250, Lot No. 073113 exp 10/9/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on August 10, 1995. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 250 plates were distributed. REASON Device was contaminated with bacteria. _______________ PRODUCT Brain Heat Infusion Agar + 5% Sheep Blood, in- vitro diagnostic device. Recall #Z-406-7. CODE Catalog No. P1160, Lot No. 071101 EXP 9/19/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on August 30, 1995. Firm-initiated recall complete. DISTRIBUTION Washington state, California, Alaska, Canada. QUANTITY 290 plates were distributed. REASON Device was contaminated with fungus. _______________ PRODUCT CDC Anaerobic Blood Agar, in-vitro diagnostic device. Recall #Z-407-7. CODE Catalog No. P1249 Lot No. 070611 EXP 9/14/95. MANUFACTURER Prepared Media Laboratory, Inc., Tualatin, Oregon. RECALLED BY Manufacturer, by fax and by telephone on September 14, 1995. Firm-initiated recall complete. DISTRIBUTION Oregon and Canada. QUANTITY 200 plates were distributed. REASON Device was contaminated with mold. -17- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II =========== _______________ PRODUCT Muscle Pig III CSP Medicated - Starter Pig Ration for Baby Pigs (100 g/ton chlortetracycline, 100 g/ton sulfathiazole and 50 g/ton penicillin) - 50 lb bags. Manufactured for the reduction of cervical abscesses, treatment of bacterial swine enteritis and maintenance of weight gain. Recall #V-032-7. CODE K46579 (manufactured 7/31/96) MANUFACTURER MFA, Inc., Kirksville, Missouri. RECALLED BY Manufacturer, by telephone on or about January 8, 1997. Firm-initiated recall complete. DISTRIBUTION Missouri and Iowa. QUANTITY 114 50-pound bags were distributed. REASON Product was tested by the Iowa Department of Agriculture and analysis showed product did not contain any chlortetracycline or penicillin. Further testing on returned feed revealed product was subpotent in chlortetracycline (7% labeled claims), sulfathiazole (15% of labeled claims) and penicillin (14% of labeled claims). -18- END OF ENFORCEMENT REPORT FOR APRIL 9, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for