Gabapentin Oral Solution recall: CGMP Deviations
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…
Why was Gabapentin Oral Solution recalled?
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
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?
Batch# 359774; Exp. 09/02/19
- Product
- 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…
- Recalling firm
- Akorn Inc
- Quantity
- 4,885 bottles
- Distribution
- Nationwide
- Recall date
- January 17, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)