Apotex Recalls Losartan Potassium Tablets for Uniformity Issues
Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets 50 mg because the product may not meet blend uniformity specifications.
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 the hazard involves a potential failure to meet blend uniformity specifications, which is a quality control issue without reported injuries or illnesses.
Plain-English summary
Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets USP, 50 mg, 90-count bottles. The recall is due to the product potentially failing to meet the limit for blend uniformity specification.
The affected product is identified by Lot # KN1449 with an expiration date of 06/2015. The NDC number is 60505-3161-9. The tablets were manufactured for Apotex Inc. by Apotex Research Private Limited in Bangalore, India.
The product was distributed nationwide, including Hawaii and Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23,076
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 #: KN1449
- Exp 06/2015
Distribution
Part of a larger recall action
This product is one of 4 recalled by Apotex Inc. 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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