Drug 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
D-0301-2021
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 87462
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,183 unit dose cups
- Official record key
drug-enforcement:D-0301-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Code information: Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
out of specification