Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations
Apotex Corp. is voluntarily recalling Torsemide Tablets 20 mg due to CGMP deviations. The recall covers 35,819 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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect.
Plain-English summary
Apotex Corp. is voluntarily recalling Torsemide Tablets, 20 mg, 100-count bottles. 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 is manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida. The specific NDC number is 60505-0234-01. The recall involves 35,819 bottles, totaling 358,190,000 tablets. The affected lots are KT5981, KT5982, and KT5983, all with an expiration date of 01/17.
The product was distributed throughout the United States. The recall was initiated by the firm and is voluntary. The recall status is currently terminated as of June 15, 2022. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates.
The recalled product
- Product
- Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
- Manufacturer
- Apotex Corp.
- 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 (4)
- Lot #: KT5981
- KT5982
- KT5983
- Exp. Date 01/17.
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.
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