The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D1834-2015·Announced 2015-10-07

Apotex Recalls Verapamil Hydrochloride Extended-Release Tablets for Dissolution Failure

Apotex Inc. is recalling 2,075 bottles of Verapamil Hydrochloride Extended-Release tablets, 240 mg, because one lot failed to meet dissolution specification limits.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Apotex Inc. is voluntarily recalling 2,075 bottles of Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles. The affected product is identified by Lot # KP2621 with an expiration date of 8/2015. The recall is being conducted because the product failed to meet the first stage dissolution specification limits.

The affected product was distributed nationwide and in Puerto Rico. Verapamil Hydrochloride is a prescription medication used to treat certain heart and blood pressure conditions. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

Consumers with this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
Manufacturer
Apotex Inc.
Category
Drug — Cardiovascular
Hazard
Affected units
2,075

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 (2)

  • Lot #: KP2621
  • Exp 8/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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