Brandywine theophylline ER tablets recalled for stability testing gap
Brandywine Pharmaceuticals is recalling one lot of theophylline extended-release tablets, 100 mg, because stability testing for the product was interrupted at a third-party lab. Stability testing checks whether a medicine stays within its quality standards over time. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the bottle for NDC 71321-500-10, lot 405617, and expiry 03/31/2028.
- Contact your pharmacy or prescriber for a replacement before stopping this medication.
- Do not stop taking theophylline suddenly without talking to your doctor, as this can affect your breathing control.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
- Sold in
- Nationwide
- Made for
- Adults (under 0 months)
This recall covers 2 products — see all of them.
Details
- Units affected
- 1,620 100-count bottles
- Illnesses reported
- None reported
- Manufactured in
- 600 W Strasburg Rd, West Chester, Pennsylvania, United States
- Classification
- Class II
- Recall number
- D-0110-2027
In the FDA's words
- Description
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10 CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory Lot: 405617, Expiry: 03/31/2028 Distribution: Nationwide within U.S Affected quantity: 1,620 100-count bottles
- Hazard
- CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321… (this page)D-0110-2027 · 1,620 100-count bottles
- Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321…D-0111-2027 · 1,332 100-count bottles