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

FDA recall notice · announced January 17, 2018 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Batch# 359774; Exp. 09/02/19
Quantity: 4,885 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.