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.
DATEREG
12/27/1995
ENFORCEMENT REPORT FOR 12/27/95
December 27, 1995 95-52
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
==========================
_______________
UPDATE Recall #D-035-6, Piroxicam Capsules, USP 20 mg,
manufactured by Mutual Pharmaceutical Company, Inc.,
Philadelphia, Pennsylvania, which appeared in the December
13, 1995 Enforcement Report has been extended to include the
following lot numbers:
24936 EXP 2/96, 27639 EXP 2/96, 27641 EXP 2/96, 28536 EXP
6/96, 28538 EXP 7/96, 29551 EXP 11/96, 30071 EXP 1/97, 30073
EXP 1/97, 30075 EXP 2/97, 30902 EXP 5/97, 30904 EXP 5/97,
31386 EXP 7/97, 31777 EXP 8/97, 31779 EXP 8/97, 27638 EXP
2/96, 27640 EXP 2/96, 28535 EXP 6/96, 28537 EXP 6/96, 29550
EXP 11/96, 29552 EXP 11/96, 30072 EXP 1/97, 30074 EXP 1/97,
30076 EXP 2/97, 30903 EXP 5/97, 31385 EXP 7/97, 31387 EXP
7/97, 31778 EXP 11/96, 31780 EXP 8/97.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Hemorrhoidal HC 25 mg Suppositories (Hydrocortisone Acetate
25 mg). Recall #D-043-6.
CODE Lot #A001.
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter on December 6, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 4,845 boxes (12 units per box) were distributed.
REASON Potency not assured through expiration date.
_______________
PRODUCT Miochol brand of Acetylcholine Chloride Intraocular Solution
1:100 and Miochol-E brand of Acetylcholine Chloride
Intraocular solution with Electrolyte Diluent, Rx products
used to obtain miosis of the eye: (a) Miochol Univials;
(b) Miochol with Steri-Tags; (c) Miochol System Pack;
(d) Miochol System Pack Plus; (e) Miochol E with Steri-Tags;
(f) Miochol E System Pack. Recall #D-044/049-6.
CODE Lot numbers and EXP dates: (a) S5082D 11/96, S5093D 9/96,
T3202D 9/96, T3217D 10/96; (b) S5081D 6/96, S5080D 6/96,
S5084D 6/96, S5085E 8/96, S5091D 8/96, S5092D 8/96, T3201D
9/96, T3206D 9/96, T3208D 9/96, T3207D 9/96, T3211D 10/96;
(c) S5083D 6/96, S5089D 8/96, S5090D 8/96, T3200D 9/96,
T3203E 9/96, T3204D 9/96, T3210D 9/96, T3213D 10/96; (d)
SL4924 4/96, TA4600 5/96, TB4601 6/96, TB4602 6/96, TC4604
8/96, TC4603 8/96, TD4605 8/96, TE4607 9/96, TE4609 9/96;
(e) S4864D 6/96, S4865D 6/96, S4870D 10/96, T3100D 11/96,
T3101D 11/96, T3102D 11/96, T3104D 11/96, T3106D 12/96; (f)
S4860D 5/96, S4866D 6/96, S4869D 6/96, S4872D 10/96, T3103D
11/96. (Note: Additionally, all lots with expiration dates
prior to 9/96 are also included in this recall.)
MANUFACTURER OMJ Pharmaceuticals, Inc., San German, Puerto Rico.
RECALLED BY Ciba Vision Ophthalmics, Division of Ciba Vision
Corporation, Duluth, Georgia, by letter followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 45,000 units of the lots of Miochol and
100,000 units of the lots of Miochol-E remained on market at
time of recall initiation.
REASON Products do not meet pH specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets, Pooled. Recall #B-126-6.
CODE Unit #051795-1.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on May 18, 1995. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an extended expiration
date, was distributed.
_______________
PRODUCT (a) Red Blood Cells. Recall #B-130-6.
CODE Unit #K04183.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter dated July 27, 1995. Firm-initiated
recall complete.
-2- DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor with a
history of ear and nose piercing within 12 months of
donation, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-133/134-6.
CODE Unit #7743231.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letters dated August 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas, New Jersey.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who had sexual
contact with an intravenous (IV) drug user, were
distributed.
_______________
PRODUCT Platelets, Pooled. Recall #B-135-6.
CODE Unit #P52692 - contains Platelets, Unit #9219754.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on June 29, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 pooled unit.
REASON Blood product, which tested negative for the antibody to the
hepatitis C virus encoded antigen (anti-HCV), but was
collected from a donor who previously tested repeatedly
reactive for anti-HCV, was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets.
Recall #B-136/138-6.
CODE Code numbers: (a) 100, 103; (b) 200, 210, 218, 230, 240,
260, 268, 269, 270; (c) 350 (Pooled 353).
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, Meridian, Mississippi.
RECALLED BY Manufacturer, by letters dated July 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 10,481 units collectively.
REASON Blood products, collected from donors with an abbreviated
health history interview, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-140/143-6.
CODE Unit numbers: (a) 14G99483, 14G02712, 14G10978; (b)
14G02712, 14G10978; (c) 14G02712; (d) 14G99483, 14G10978.
MANUFACTURER American Red Cross, Yakima, Washington.
-3- RECALLED BY Manufacturer, by letters dated December 19, 1994, and
January 5, 1995. Firm-initiated recall complete.
DISTRIBUTION Washington, Alabama, California, Florida.
QUANTITY (a) 3 units; (b) 2 units; (c) 1 unit; (d) 2 units.
REASON Blood products collected from a donor who previously tested
HCV repeat reactive, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-144-6.
CODE Unit #56H00385.
MANUFACTURER American Red Cross Blood Services, Syracuse, New York.
RECALLED BY Manufacturer, by letter dated October 5, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but was
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-145-6.
CODE Unit #21GF21158.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated September 7, 1994. Firm-
initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had traveled to an
area designated as endemic for malaria, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-127-6.
CODE Unit #639954.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on March 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, which was irradiated and labeled with an
extended expiration date, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-128-6.
CODE Unit numbers 652053 and 652039.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on or about March 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 2 units.
-4- REASON Blood products, which were irradiated and labeled with
extended expiration dates, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-129-6.
CODE Unit numbers: 625560 and 624468.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on or about November 11, 1994.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 2 units.
REASON Blood products, which were irradiated and labeled with
extended expiration dates, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-131-6.
CODE Unit #K04183.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter dated July 27, 1995. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor with a
history of ear and nose piercing within 12 months of
donation, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-132-6.
CODE Unit numbers: 0426159, 0426172, 0426173, 0426175, 0426177,
0426218.
MANUFACTURER Bergen Community Regional Blood Center, Paramus, New Jersey.
RECALLED BY Manufacturer, by telephone on November 2, 1994. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 6 units.
REASON Blood products, which were irradiated and labeled with an
extended expiration date, were distributed.
_______________
PRODUCT Plasma (FFP, Recovered). Recall #B-139-6.
CODE Unit numbers: 510, 520, 530, 540.
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, Meridian, Mississippi.
RECALLED BY Manufacturer, by letters dated July 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 10,481 units collectively.
Blood products, collected from donors with an abbreviated
health history interview, were distributed.
_______________
PRODUCT (a) Platelets (Pooled); (b) Fresh Frozen Plasma.
Recall #B-148/149-6.
-5- CODE Unit numbers: (a) P43822; (b) 6176424.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter dated October 5 and 20, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas, California.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to Red Blood Cells which were
contaminated with a gram positive rods cultured to be
Propionibacterium acnes, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Modular Patient System (MPS-3000) Acute Care Bed.
Recall #Z-245-6.
CODE Beds affected were manufactured during the month of December
1993. Serial numbers include the following ranges 93121501-
93121741, 93121768-93121837, 93121843-93121852, 94021641-
94021643.
MANUFACTURER Stryker Patient Care, Kalamazoo, Michigan.
RECALLED BY Manufacturer. All involved beds were corrected by 1/11/95.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 314 units were distributed.
REASON Exposed clips could lacerate patient's skin.
_______________
PRODUCT Lifestyles Spermicidally Lubricated Condoms, 12 individually
wrapped condoms per box. Recall #Z-246-6.
CODE Product #1812, Lot #310018300 EXP 9/96.
MANUFACTURER Ansell, Inc., Troy, Alabama.
RECALLED BY Ansell, Inc., Dothan, Alabama, by letter dated November 20,
1995, and by press release issued in the State of Hawaii.
Firm-initiated recall complete.
DISTRIBUTION California, Colorado, Hawaii, Illinois, Maryland, Michigan,
Minnesota, New Jersey, New York, Ohio, Pennsylvania,
Tennessee, Utah.
QUANTITY 4,608 boxes of 12 condoms were distributed.
REASON Product failed the FDA water leak test.
_______________
PRODUCT Lifestyles Assorted Color Condoms with Spermicidal
Lubricant, strips of 1000. Recall #Z-247-6.
CODE 503002200, 503004800, 50403900.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
RECALLED BY Manufacturer, by telephone June 6, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, Connecticut, Louisiana, Maine, Massachusetts,
Michigan, New York, Ohio, Oklahoma, Pennsylvania,
Washington, Wisconsin.
QUANTITY Firm estimates none remains on the market.
REASON Products failed the firm's water leak test.
-6- _______________
PRODUCT MicroScan Dried Overnight (Positive and Negative Panels),
used for aerobic bacterial identification and antimicrobial
susceptibility testing and Rapid Chromogenic Identification
Panels:
(a) Conventional Dried Negative; (b) Conventional Dried
Positive; (c) Rapid Chromogenic Panels; (d) Custom Panels
(Conventional Dried Negative or Positive, as per Customer);
(e) International Conventional Dried (Positive and/or
Negative, Specific to needs to Nationality of Customer).
Recall #Z-249/253-6.
CODE Lot numbers:
(a) B1017-102 25AUG96;
B1017-27 28JUN96, 18JUL96;
B1017-30 28APR96, 23JUN96, 06JUL96,
18AUG96;
B1017-50 21APR96, 06MAY96, 16MAY96,
22MAY96, 26JUN96, 30JUN96,
28JUL96, 17AUG96, 08SEP96;
B1017-55 14JUN96;
B1017-72 22MAY96, 22JUN96, 11JUL96,
12JUL96, 11AUG96;
B1017-74 09JUN96, 20JUN96, 25JUL96;
B1017-75 28APR96, 08MAY96, 12MAY96,
01JUN96, 14JUL96, 03AUG96;
B1017-76 18AUG96;
B1017-78 17APR96, 18MAY96, 30MAY96,
22JUN96, 27JUN96, 28JUN96,
11JUL96, 13JUL96, 17JUL96,
24JUL96, 26JUL96, 02AUG96,
03AUG96, 09AGU96, 16AUG96,
21AUG96, 26AGU96, 30AUG96,
31AUG96, 01SEP96;
B1017-80 30MAY96, 30JUN96, 17AUG96;
B1017-82 28APR96, 02MAY96, 10MAY96,
15MAY96, 17MAY96, 20MAY96,
01JUN96, 16JUN96, 21JUN96,
11JUL96, 01AUG96, 30AUG96,
28AUG96, 29AUG96, 05SEP96;
B1071-87 17APR96, 25APR96, 27APR96,
26MAY96, 09JUN96, 15JUN96,
27JUN96, 12JUL96, 20JUL96,
10AUG96, 21AUG96;
B1017-88 27APR96, 26MAY96, 05JUN96,
09JUN96, 15JUN96, 29JUN96;
B1017-89 18APR96, 17MAY96, 14JUN96,
25AUG96, 07SEP96;
(b) B1017-60 18APR96, 26APR96, 27APR96,
09MAY96, 17MAY96, 23MAY96,
24MAY96, 30MAY96, 19JUN96,
21JUN96, 27JUN96, 17JUL96,
18JUL96, 20JUL96, 02AUG96,
-7- 21AUG96, 22AUG96, 25AUG96,
26AUG96, 28AUG96, 30AUG96,
01SEP96;
B1017-61 17APR96, 08MAY96, 16MAY96,
23MAY96, 31MAY96, 12JUN96,
13JUN96, 19JUN96, 29JUN96,
20JUL96, 17AUG96, 19AUG96,
22AUG96, 26AUG96, 30AUG96,
31AUG96, 01SEP96;
B1017-62 14APR96, 18APR96, 26APR96,
10MAY96, 13JUL96, 14JUL96,
20JUL96, 01AUG96, 29AUG96;
B1017-90 06JUL96, 01APR96;
B1017-94 06JUL96;
B1012-10B 01APR96;
(c) B1012-10B 10APR96, 14APR96, 09JUN96;
B1017-02 10FEB96;
(d) B1017-47DL 17MAY96, 08AUG96;
B1017-47DLU 17MAY96;
B1019-17SV 19MAY96;
B1019-4VA 17APR96;
B1019-16CHC 05SEP96;
(e) B1016-21A 14JUL96, 24AUG96;
B1016-22A 19JUN96, 18JUL96, 01AUG96;
B1016-23A 07SEP96;
B1016-26A 25MAY96, 21JUN96, 26AUG96;
B1016-29A 28JUL96;
B1016-42A 04AUG96;
B1016-46A 30AUG96;
B1016-48A 31AUG96;
J1016-23A 22AUG96;
J1016-25A 07SEP96;
J1016-26A 06JUL96;
J1016-27A 12JUN96, 10JUL96, 26JUL96,
02SEP96;
J1016-29A 24APR96, 28AUG96;
J1016-30A 18APR96, 19APR96, 20APR96
19MAY96, 08JUN96, 05SEP96;
J1016-31A 24APR96;
J1016-41C 23JUN96.
MANUFACTURER Dade International, MicroScan, Inc., West Sacramento,
California.
RECALLED BY Manufacturer, by letter dated September 22, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 334,000 panels were produced between April 12
and September 8, 1995.
REASON The locator well on some panels made with cavity 8 plastic
appear to be warped and were not being recognized by the
autoScan -4 instrument, causing an "unrecognized panel error
message", or potential misreads with the biochemical and MIC
results.
-8- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Diamedix VZV IgG Microassay, Catalog order #783-380, used
for the detection and quantitation of Varicella-Zoster virus
(VZV) specific IgG antibody in human serum to aid in the
determination of immu status and diagnosis of VZV infection.
Recall #Z-248-6.
CODE Lot numbers: T1804A, T1804B, T18004C.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter July 31, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 671 tests were distributed.
REASON The VZV test wells were incorrectly labeled as HS1.
-9-
END OF ENFORCEMENT REPORT FOR DECEMBER 27, 1995. BLANK PAGES MAY
FOLLOW.
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