Prescription Drug Recalled Due to Failed Dissolution Specifications
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves failed dissolution specifications in a prescription medication, representing a risk-of-harm scenario where the drug may not be properly absorbed. No illnesses or injuries have been reported in the source text.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Extended Phenytoin Sodium Capsules, USP, 100 mg in 100-count bottles. Lot HM03221A (expiration date 12/31/2023) is affected. Approximately 9,263 bottles have been distributed nationwide throughout the United States and Puerto Rico.
The recall was initiated due to failed dissolution specifications. Dissolution specifications are standards that ensure tablets properly dissolve in the digestive system to allow drug absorption.
Patients and healthcare providers should be aware of this recall. For additional information or questions about this recall, contact the recalling manufacturer, Amneal Pharmaceuticals, or your healthcare provider.
The recalled product
- Product
- EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Hazard
- dissolution-failure
- bioavailability-issue
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 # HM03221A
- Exp. date 12/31/2023
UPCs (2)
- 0365162212037
- 0365162212105
Distribution
Distributed nationwide across the United States.
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