Akorn Inc recalls Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Ph
Recalled January 17, 2018 · FDA recall D-0211-2018 · Akorn
Hazard
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. · FDA Class III
Units
4,885 bottles
Sold at
Nationwide
Description
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
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
Manufacturer(s)
Akorn Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →