September 22, 1999
Merrem (Meropenem for Injection) Recalled by
Marsam Pharmaceuticals, Inc.
Cherry Hill, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Marsam Pharmaceuticals, Inc. is recalling Merrem
(Meropenem for Injection) because of current good manufacturing practice deviations (at
Merrem (Meropenem for Injection), used for
intra-abdominal infections and bacterial meningitis:
a) 500 mg in 20 ml and 100 ml vials;
b) 1 gram in 30 ml, and 100 ml vials, and in 15 ml ADDVantage
NDCs 0310-0325-11 (100 ml vial/500 mg), 0310-0325-20 (20 ml vial/500 mg),
0310-0321-11 (100 ml vial/1 gram), 0310-0321-15 (15 ml vial/1 gram), and 0310-0321-30 (30
ml vial/1 gram).
Recall #D-410/411-9. Class II
The expiration period for all lots is 8/99 - 11/01. The lot numbers are as
follows:500 mg lots: 4082Y, 3105A, 3192B, 3193B, 3625A, 3720Y, 4083Y, 4103A, 4323A, 4419Y,
4695A, 4722A, 4777A, and 4778A. 1 gram lots: 3210Y, 3228Y, 3869Y, 4409Y, 3099A, 3912A,
4410Y, 4804Y, 3101A, 3102A, 3103A, 3107A, 3108A, 3176B, 3178B, 3179B, 3180B, 3182B, 3183B,
3184B, 3190B, 3191B, 3212Y, 3213Y, 3214Y, 3621A, 3622A, 3717Y, 3913A, 3914A, 3915A, 4078Y,
4078Y, 4080Y, 4081Y, 4100A, 4101A, 4321A, 4322A, 4324A, 4325A, 4413Y, 4414Y, 4415Y, 4719A,
4733A, 4734A, and 4806Y.
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
AstraZeneca, a business unit of Zeneca, Inc., Wilmington, Delaware, by letter on
August 13, 1999. Firm-initiated recall ongoing.
Nationwide and Canada.
Approximately 2,500 cases remained on market at time of recall initiation.
Questions concerning this recall may be directed
to the Food and Drug Administration at 1-800-INFO-FDA.
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