Recalls / Class II
Class IID-003-2013
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.
- Affected lot / code info
- Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Why it was recalled
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- a) 2424 Cartons b) 2675 Cartons
- Distribution pattern
- One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Timeline
- Recall initiated
- 2012-08-21
- FDA classified
- 2012-10-03
- Posted by FDA
- 2012-10-10
- Terminated
- 2013-11-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-003-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.