Caraco Recalls Nimodipine Capsules Due to Crystallization
Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The presence of crystals is a quality defect that may affect drug performance, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Caraco Pharmaceutical Laboratories Ltd. is recalling Nimodipine Capsules 30 mg, which are prescription-only and intended for institutional use. The recall involves two specific lot numbers: 3305.039B (NDC 57664-135-64) and 3305.039A (NDC 57664-135-65), both with an expiration date of 07/13.
The reason for the recall is the presence of crystals of Nimodipine within the capsule solution. The affected products were distributed to one direct account and 78 sub-accounts. The total quantity recalled is 2,424 cartons of the 30-count unit dose capsules and 2,675 cartons of the 100-count unit dose capsules.
Institutional customers should stop using the affected lots and contact Caraco Pharmaceutical Laboratories for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- 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…
- Manufacturer
- Caraco Pharmaceutical Laboratories Ltd.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: a) 3305.039B
- Exp 07/13
- b) 3305.039A
Distribution
Distributed in 1 state:
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