D-0211-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- December 15, 2017
- Termination Date
- April 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,885 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Distribution Pattern
Nationwide
Code Information
Batch# 359774; Exp. 09/02/19