Valeant Recalls Nifedipine Extended-Release Tablets Due to Dissolution Failures
Valeant Pharmaceuticals is recalling Nifedipine Extended-Release Tablets, 90 mg, because some lots failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct contamination or structural defect causing immediate severe injury.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles. The recall affects 93,237 bottles distributed nationwide in the United States. The product is manufactured for Teva Pharmaceuticals USA and manufactured in Canada by Valeant Pharmaceuticals International, Inc.
The recall was initiated because high out-of-specification dissolution results were found at the 1-hour time point. This means the tablets may not dissolve at the rate required by the United States Pharmacopeia (USP) standards.
Consumers with these specific lot numbers should contact their healthcare provider or pharmacist for guidance. The affected lots include 1309T27, 1309T28, 1311T33, 1311T34, 1312T40, 1312T41, 1403T23, 1403T21, 1405T21, and 1405T22, with expiration dates ranging from August 2015 to April 2016.
The recalled product
- Product
- Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 93,237
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 (16)
- Lot #: 1309T27
- Expiry: 8/15
- Lot #: 1309T28
- Lot #: 1311T33
- Expiry: 10/15
- Lot #: 1311T34
- Lot #: 1312T40
- Expiry: 11/15
- Lot #: 1312T41
- Lot #: 1403T23
- Expiry: 02/16
- Lot #: 1403T21
- Lot #: 1405T21
- Expiry: 04/16
- Lot #:1405T22
- Expiry: 04/16.
Distribution
Distributed nationwide across the United States.
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