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manufacturing process; AADA was withdrawn.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
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
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%).
Alan W Davidson
General Secretary, International Pharmaceutical Federation
a.davidson@fip.nl or visit our web site at
http://www.pharmweb.net/pwmirror/pw9/fip/pharmweb92.html
|