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Crystallization Prompts Nimodipine Tablet Recall

Filed September 5th, 2012 Laurie

Sun Pharmaceutical Industries Inc. has announced that it is voluntarily recalling one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. The recall was launched out of an abundance of caution because of the presence of crystals of nimodipine within the capsule solution. No adverse events have been reported.

According to the Food and Drug Administration’s press release, the crystallization of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. The health implications are not known.

Nimodipine Capsules are used to decrease problems linked to bleeding in the brain. The affected capsules contain a clear yellow solution in oblong light yellow softgel capsules with “135” printed on them in black ink. The product is supplied in unit dose blisters of 30 and 100, as described below. The affected product was distributed nationwide between January 19, 2012 and April 24, 2012.

According to the Food and Drug Administration’s press release, the crystallization of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability.

The following products are subject to recall:

  • Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25×4)
  • Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5×6)

Patients and healthcare providers should stop using the products and call 1-800-967-5952 (Option 1 then Option 3) for more information about the recall, Monday through Friday, from 8 a.m. to 5 p.m.

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