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Safety Alerts
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 contract manufacturer).

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 vials.
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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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.