The Recall Desk
ModerateFDA (Drugs)·D-0245-2017·Announced 2017-01-11

Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

Apotex Corp. is voluntarily recalling Torsemide Tablets, 5 mg, due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers 13,179 bottles distributed in the United States.

What this means for you

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 is a voluntary precautionary recall due to CGMP deviations without reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Apotex Corp. is voluntarily recalling Torsemide Tablets, 5 mg, 100-count bottles, NDC 60505-0232-01. The recall was initiated on December 14, 2016, and is classified as Class II by the FDA. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.

The affected product was manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, FL. The specific lot number is KW8378 with an expiration date of 05/17. A total of 13,179 bottles (1,317,900 tablets) were distributed in the United States.

This recall is voluntary and was initiated by the firm. The recall status is currently Terminated. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or credit, as per standard recall procedures.

The recalled product

Product
Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
Manufacturer
Apotex Corp.
Category
Drug — Prescription Medication
Hazard

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 #: KW8378
  • Exp. Date 05/17.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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