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Recall Observatory FDA recall evidence

Drug product

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

D-0301-2021

March 08, 2021

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 87462
Status
Terminated
Classification
Class II
Quantity
8,183 unit dose cups
Official record key
drug-enforcement:D-0301-2021

Official wording

Reason: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

Code information: Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification