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.
Reported: June 21, 2023 Initiated: May 30, 2023 #D-0876-2023
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 9,056 bottles
- Distribution
- LA, PA and OH.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 9,056 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 21, 2023. Severity: Moderate. Recall number: D-0876-2023.
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