Recalls / Class II
Class IID-1183-2018
Product
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
- Affected lot / code info
- Lots: 1165280100, 1165280101, EXP 3/2019
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 23,788 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-24
- FDA classified
- 2018-09-07
- Posted by FDA
- 2018-09-12
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1183-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.