Gabapentin Oral Solution recall: Impurity Out of Spec
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…
Why was Gabapentin Oral Solution recalled?
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
- 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…
- Recalling firm
- Akorn, Inc.
- Quantity
- 8,183 unit dose cups
- Distribution
- Nationwide USA
- Recall date
- March 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)