FDA Drug Class III — Least Serious

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

Hazard

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

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Products

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
UPC
Batch# 359774; Exp. 09/02/19

Units Affected

4,885 bottles

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