Reported Jun 21, 2023 · Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal…
Amneal Pharmaceuticals of New York, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle
- Distributed byAmneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10
- Lot codes and dates
Lot # HL00721AExp. 12/2023
- Amount recalled
- 9,056 bottles
Where it was sold
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
This product could cause temporary or reversible health problems — stop using it.
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