AvKARE Recalls Oxybutynin Chloride Tablets for Failed Dissolution Specifications
AvKARE Inc. is recalling Oxybutynin Chloride Extended-Release Tablets because they failed to meet dissolution specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety risk like contamination or mislabeling.
Plain-English summary
AvKARE Inc. is recalling Oxybutynin Chloride Extended-Release Tablets USP 10 mg. The recall involves 100-tablet and 500-tablet bottles (NDC 42291-634-01 and NDC 42291-634-50) manufactured for AvKARE, Inc. in Pulaski, TN. The specific lots affected are 22738 and 22739, both with an expiration date of 07/2020.
The reason for the recall is that the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate and amount. When a drug fails these specifications, it may not deliver the intended therapeutic effect to the patient.
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product is found, it should be returned to the supplier or the recalling firm, AvKARE Inc.
The recalled product
- Product
- OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
- Brand
- OXYBUTYNIN CHLORIDE
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Drug
- 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 (1)
- Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
UPCs (4)
- 0342291635012
- 0342291633018
- 0342291634503
- 0342291633506
Distribution
Distributed nationwide across the United States.
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