FDAClass IIOctober 10, 2012

Nimodipine Capsules 30 mg recall

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.

Why was Nimodipine Capsules 30 mg recalled?

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13

Product
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Recalling firm
Caraco Pharmaceutical Laboratories Ltd.
Quantity
a) 2424 Cartons b) 2675 Cartons
Distribution
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Recall date
October 10, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls