FDA-Drug2018-01-17Class III
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
Akorn Inc
Hazard
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Sold states
Nationwide
Affected count
4,885 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0211-2018Don't want to check this manually?
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