Recalls / Class II
Class IID-66014-001
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
- Brand name
- Extended Phenytoin Sodium
- Generic name
- Phenytoin Sodium
- Active ingredient
- Phenytoin Sodium
- Route
- Oral
- NDC
- 65162-212
- FDA application
- ANDA040765
- Affected lot / code info
- Batch/Lot HL50611, exp. 1/2014
Why it was recalled
Failed dissolution specifications; 18 month CRT
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC.
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 85 Adams Avenue, N/A, Hauppauge, New York 11788
Distribution
- Quantity
- 895 - 1000 count bottles
- Distribution pattern
- IL, NH, NJ, NY, OH, RI, TN
Timeline
- Recall initiated
- 2013-08-17
- FDA classified
- 2013-11-04
- Posted by FDA
- 2013-11-13
- Terminated
- 2014-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66014-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.