Amneal Recalls Extended Phenytoin Sodium Capsules Due to Dissolution Failure
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium Capsules because they failed to meet dissolution specifications.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC. is recalling Extended Phenytoin Sodium Capsules, USP, 100 mg. The recall is limited to bottles containing 895 to 1,000 capsules with NDC 65162-212-11, Batch/Lot HL50611, and an expiration date of 1/2014.
The recall was initiated because the product failed to meet dissolution specifications. This means the capsules may not release the medication in the body as intended, potentially affecting the drug's efficacy.
The affected product was distributed in Illinois, New Hampshire, New Jersey, New York, Ohio, Rhode Island, and Tennessee. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC.
- Category
- Drug — Anticonvulsant
- 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)
- Batch/Lot HL50611
- exp. 1/2014
UPCs (2)
- 0365162212037
- 0365162212105
Distribution
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