Reported Jan 17, 2018 · Terminated
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech…
Akorn Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn Inc · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only
- Manufactured byHi-Tech Pharmacal Co., Inc. Amityville, NY 11701
- NDC50383-311-47
- Lot codes and dates
Batch# 359774Exp. 09/02/19
- Amount recalled
- 4,885 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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