Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reported: March 20, 2019 Initiated: March 1, 2019 #D-0990-2019
Product Description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- a) 2947 and b) 3379
- Distribution
- Nationwide.
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Recalled by AVKARE Inc.. Units affected: a) 2947 and b) 3379.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Low. Recall number: D-0990-2019.
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