Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 1165280100, 1165280101, EXP 3/2019
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1183-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2018
- FDA report date
- Sep 12, 2018
- Quantity
- 23,788 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1183-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80880
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lots: 1165280100, 1165280101, EXP 3/2019
- Postal code
- 60045-4862
- Report date
- Sep 12, 2018
- Product type
- Drugs
- Recall number
- D-1183-2018
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 23,788 100-count bottles
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2018