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FDARecalled Nov 4, 2026 · #D-0110-2027

Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory Classification: Class II Distribution: Nationwide within U.S

Product details

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
Type
Drugs
Manufacturer
Brandywine Pharmaceuticals, LLC
Model numbers
405617
UPCs
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