Recalls / Class II
Class IID-0301-2021
Product
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
- Affected lot / code info
- Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
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
- 8,183 unit dose cups
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-03-08
- FDA classified
- 2021-03-16
- Posted by FDA
- 2021-03-24
- Terminated
- 2022-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0301-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.