FDA Drug recall D-003-2013
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-13…
- FDA Drug
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-13… by Caraco Pharmaceutical Laboratories, citing crystallization: Presence of crystals of Nimodipine within the capsule solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-003-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-21 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Caraco Pharmaceutical Laboratories |
| Distribution | MI |
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.
Reason
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Identifiers
| code_info | Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Caraco Pharmaceutical Laboratories
- Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only,…
FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories - Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only,…
FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories - Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles
FDA Drug · Class II · 2014-07-09 · Caraco Pharmaceutical Laboratories - Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac…
FDA Drug · Class II · 2014-07-02 · Caraco Pharmaceutical Laboratories - Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5)
FDA Drug · Class II · 2014-05-07 · Caraco Pharmaceutical Laboratories
All Caraco Pharmaceutical Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-003-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.