Extended Phenytoin Sodium Capsules recall: Failed Dissolution
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Why was Extended Phenytoin Sodium Capsules recalled?
Failed Dissolution Specifications
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 # HM03221A, Exp. date 12/31/2023
- Product
- Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 9,263 100-count bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)