Brandywine Pharmaceuticals, Llc: Theophylline Extended-release Tablets, 200 Mg
- Recalling firm
- Brandywine Pharmaceuticals, LLC
- Product
- Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
- Reason
- CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/45bee7cd-3c77-4051-9d0e-24c4dde26bf0