Recalls / Class II
Class IID-0076-2018
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
- Affected lot / code info
- Lot # AP160016; Exp. 05/18
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 118 Beaver Trl, N/A, Glasgow, Kentucky 42141-1273
Distribution
- Quantity
- 14,000 vials
- Distribution pattern
- MS, NC, OH, TX, UT
Timeline
- Recall initiated
- 2017-08-31
- FDA classified
- 2017-11-13
- Posted by FDA
- 2017-11-22
- Terminated
- 2019-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0076-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.