Brandywine Recalls Theophylline Extended-Release Tablets Due to Stability Testing Interruption
Brandywine Pharmaceuticals is recalling 1,332 bottles of Theophylline Extended-Release Tablets because an interruption in stability testing at a third-party laboratory created a potential quality concern.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a CGMP deviation involving an interruption in stability testing. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Brandywine Pharmaceuticals, LLC is recalling 1,332 100-count bottles of Theophylline Extended-Release Tablets, 200 mg, Rx Only (NDC: 71321-501-10). The recall is due to an interruption in the ongoing stability testing program conducted at a third-party laboratory, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is identified by Lot 405620 with an expiration date of 03/31/2028. The product was distributed nationwide within the United States. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on returning the medication or obtaining a replacement.
The recalled product
- 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.
- Manufacturer
- Brandywine Pharmaceuticals, LLC
- Category
- Drug — Prescription Medication
- 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 (2)
- Lot: 405620
- Expiry: 03/31/2028.
Distribution
Distributed nationwide across the United States.
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