AvKARE Recalls Mesalamine Tablets for Failed Dissolution Specifications
AvKARE Inc. is recalling specific lots of Mesalamine Delayed-Release Tablets because they failed to meet dissolution 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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a quality control failure (dissolution) rather than a high-risk pathogen or structural defect.
Plain-English summary
AvKARE Inc. is recalling 15,678 bottles of Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only. The product is manufactured for AvKARE Inc. in Pulaski, TN, and carries the NDC 42291-564-12.
The recall was initiated because the affected lots failed to meet dissolution specifications. The affected lots are 26085 (Exp. 07/2021), 26426 (Exp. 01/2022), 26983 (Exp. 04/2022), and 28647 (Exp. 06/2022). The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement.
The recalled product
- Product
- Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 15,678
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)
- Lots: 26085 Exp. 07/2021
- 26426 Exp. 01/2022
- 26983 Exp. 04/2022
- 28647 Exp. 06/2022
Distribution
Distributed nationwide across the United States.
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