The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-687-2013·Announced 2013-07-17

Sun Pharmaceutical Recalls Nimodipine Capsules Due to Crystallization

Sun Pharmaceutical Industries Inc. is recalling Nimodipine Capsules 30 mg due to crystallization of the active ingredient.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Nimodipine Capsules 30 mg, which are prescription-only and intended for institutional use. The recall affects 46,387 cartons of the medication, including 30-count and 100-count unit dose capsules. The product was distributed nationwide and in Puerto Rico by Caraco Pharmaceutical Laboratories, Ltd.

The recall was initiated because of crystallization of the nimodipine active ingredient. The affected lots include specific expiration dates ranging from June 2013 to March 2014. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and institutions should stop using the affected Nimodipine Capsules and contact the recalling firm for instructions on how to return or dispose of the product.

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 Laboratories…
Manufacturer
Sun Pharmaceutical Industries Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
46,387

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 (18)

  • 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
  • 3305.038A
  • Exp Jul-13
  • 3305.040A
  • 3505.041A Exp Sep-13
  • 3305.042A
  • 3305.043A
  • 3305.044A Dec-13.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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