FDA recall D-0211-2018

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

Reason for recall

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-12-15

Report date

2018-01-17

Termination date

2019-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0211-2018