Drug product
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
D-0211-2018
Product summary
- Firm
- Akorn Inc
- Event
- Event 78730
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,885 bottles
- Official record key
drug-enforcement:D-0211-2018
Official wording
Reason: CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Code information: Batch# 359774; Exp. 09/02/19
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations