Why it was recalled
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Where it was sold
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-003-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2012
- FDA report date
- Oct 10, 2012
- Quantity
- a) 2424 Cartons b) 2675 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories Ltd.
Original FDA data
Every field from FDA enforcement report D-003-2013, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63031
- Address
- 270 Prospect Plains Rd
- Code information
- Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
- Postal code
- 08512-3605
- Report date
- Oct 10, 2012
- Product type
- Drugs
- Recall number
- D-003-2013
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories Ltd.
- Product quantity
- a) 2424 Cartons b) 2675 Cartons
- Termination date
- Nov 19, 2013
- Reason for recall
- Crystallization: Presence of crystals of Nimodipine within the capsule solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
- Recall initiation date
- Aug 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2012