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.

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manufacturing process; AADA was withdrawn.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.

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End of Enforcement Report for