Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- March 8, 2021
- Posted
- March 24, 2021
- Recall Number
- D-0301-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,183 unit dose cups
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Distribution
Nationwide USA
Lot / Code Info
Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
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