FDA-Drug2021-03-24Class II
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Akorn, Inc.
Hazard
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Sold states
Nationwide USA
Affected count
8,183 unit dose cups
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2021Don't want to check this manually?
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