Class III
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- December 15, 2017
- Posted
- January 17, 2018
- Recall Number
- D-0211-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,885 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Distribution
Nationwide
Lot / Code Info
Batch# 359774; Exp. 09/02/19
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