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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 16, 1999

LEK Pharmaceutical and Chemical Co Recalls Cimetidine Tablets and Acyclovir Tablets or Capsules

Englewood Cliffs, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that LEK Pharmaceutical and Chemical Co. is recalling Cimetidine Tablets and Acyclovir Tablets or Capsules because of a lack of assurance of bioequivalence.

Acyclovir Tablets or Capsules, Rx used as an anti-viral medication for Herpes Simplex I:
a) 200 mg, in 100, 500 and 1,000 capsule bottles
b) 400 mg, Rx in 100, 500, and 1,000 tablet bottles
c) 800 mg, Rx in 100, 500, and 1,000 tablet bottles

Labels and NDC Numbers --

Schein Pharmaceuticals
0365-2692-01, 100 capsules/200 mg
0364-2689-01, 100 tablets/400 mg
0364-2689-05, 500 tablets/400 mg
0364-2689-01, 100 tablets/800 mg

Mylan Pharmaceutical Inc.
0378-1464-01, 100 tablets/400 mg
0378-1468-01, 100 tablets/800 mg

Par Pharmaceutical
200 mg
49884-460-05, 500 capsules
49884-460-01, 100 capsules
49884-460-10, 1000 capsules
400 mg
49884-487-01, 100 tablets
49884-487-05, 500 tablets
49884-487-10, 1000 tablets
800 mg
49884-474-01, 100 tablets
49884-474-05, 500 tablets
49884-474-10, 1000 tablets

Cimetidine Tablets, used as a stomach acid reducer for patients with stomach ulcers
d) 200 mg, Rx and OTC, in 6,10, 12,18, 30, 50, 60, 90, and 100 count units
e) 300 mg, Rx in 100, 500, and 1,000 count bottles
f) 400 mg, Rx in 60, 100, 500, and 1,000 count bottles
g) 800 mg, Rx in 30, 100, and 250 count bottles.

Labels and NDC Numbers --

Cimetidine 200 mg OTC

Eckerd Drug Company
19458-957-61, 6 tablet blister
19458-957-62, 18 tablet blister
19458-957-63, 30 tablet blister
19458-957-64, 60 tablet blister

Albertson's
41163-229-08, 30 tablet blister

Equate --Packaged by BI-MART
50606-229-08, 30 tablet blister
50606-229-15, 60/12/30 tablet blister

Western Family Foods, Inc.
12 tablet blister and 30 tablet blister

Kaiser Permanente
00179-1308-30, 30 tablet blister
00179-1308-90, 90 tablet blister

Pharmacist Formula Marketed by: Leiner Health Products, Inc.
18 tablet blister
(special 30 tablet blister for above)
30 tablet blister
50 tablet blister

VONS
58828-229-08 30 tablet blister

Safeway Inc.
21130-229-08 30 tablet blister

Bulk shipping label
LEK Pharmaceutical and Chemical Co., d.d.
Ljubljana, Slovenia

60x6 coated tablet blister
60x6 tablets acid reducer
60x10 tablets acid reducer
60x10 coated tablets

Cimetidine 200 mg, RX

Rosemont
0832-0101-00, 100 tablet bottles

Brightstone
62939-2111-1, 100 tablet bottles

Schein
364-2591-01, 100 tablet bottles
0364-2591-01, 100 tablet bottles

Martec
52555-708-01, 100 tablet bottles

Qualitest
0603-2890-21, 100 tablet bottles

URL
0677-1527-01, 100 tablet bottles

Cimetidine 300 mg

Rosemont
0102-00 100, tablet bottles
0832-0102-50, 500 tablet bottles
0832-0102-10, 1000 tablet bottles

Brightstone
62939-2121-1, 100 tablet bottles

Schein
0364-2592-01, 100 tablet bottles
0364-2592-05, 500 tablet bottles

Martec
52555-709-01, 100 tablet bottles

Apothecon
59772-0229-5, 500 tablet bottles

Qualitest
0603-2891-28, 500 tablet bottles

URL
0677-1528-01, 100 tablet bottles

MOVA
55370-866-07, 100 tablet bottles

Cimetidine 400 mg

Rosemont
0832-0103-06, 60 tablet bottles
0832-0103-00, 100 tablet bottles
0832-0103-50, 500 tablet bottles
0832-0103-10, 1000 tablet bottles

Brightstone
62939-2131-1, 100 tablet bottles

Martec
52555-710-01, 100 tablet bottles

Schein
0364-2593-01, 100 tablet bottles
0364-2593-05, 500 tablet bottles

URL
0677-1529-01, 100 tablet bottles
0677-1529-05, 500 tablet bottles

Novapharm
55953-436-40, 100 tablet bottles
55953-436-70, 500 tablet bottles
55953-436-80, 1000 tablet bottles

Apothecon
59772-0230-3, 100 tablet bottles
59772-0230-7, 500 tablet bottles

Qualitest
0603-2892-28, 500 tablet bottles

Cimetidine 800 mg

Rosemont
0832-0104-03, 30 tablet bottles
0832-0104-00, 100 tablet bottles
0832-0104-25, 250 tablet bottles

Martec
52555-711-01, 100 tablet bottles

Novapharm
55953-516-40, 100 tablet bottles

Schein
0364-2594-01, 100 tablet bottles
0364-2594-01

Brightstone
62939-2141-1, 100 tablet bottles

Qualitest
0603-2893-21, 100 tablet bottles

Apothecon
59772-0231-3, 100 tablet bottles
59772-0231-4, 250 tablet bottles.

Recall #D-247/253-9.

CODE
All lots within expiration date.

MANUFACTURER
LEK Pharmaceutical and Chemical Company, Ljubljana, Slovenia.

RECALLED BY
LEK, USA Englewood Cliffs, New Jersey, by telephone or fax March 7 or 9, 1999, and by letter dated April 1 or 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
New Jersey, New York, West Virginia.

QUANTITY
Acyclovir Tablets --
37,464 bottles (Par) 430,284 bottles (Schein) 740,000 bottles (Mylan)

Acyclovir Capsules --
22,110 bottles (Par) 320,378 bottles (Schein)

Cimetidine Tablets --
200 mg OTC 11,026 blisters
200 mg RX 34,866 bottles
400 mg 307,813 bottles
800 mg 130,139 bottles were distributed.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.