Extended Phenytoin Sodium Capsules recall: Failed Dissolution
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Why was Extended Phenytoin Sodium Capsules recalled?
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # HL00721A, Exp. 12/2023
- Product
- Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 9,056 bottles
- Distribution
- LA, PA and OH.
- Recall date
- June 21, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)