Why it was recalled
Crystallization; crystallized nimodipine
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 #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.
Where it was sold
Nationwide and Puerto Rico
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-687-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2013
- FDA report date
- Jul 17, 2013
- Quantity
- 46387 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries Inc.
Original FDA data
Every field from FDA enforcement report D-687-2013, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65501
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.
- Postal code
- 08512-3605
- Report date
- Jul 17, 2013
- Product type
- Drugs
- Recall number
- D-687-2013
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries Inc.
- Product quantity
- 46387 Cartons
- Termination date
- Aug 25, 2014
- Reason for recall
- Crystallization; crystallized nimodipine
- 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
- Nationwide and Puerto Rico
- Recall initiation date
- May 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2013