Reported Mar 24, 2021 · Terminated
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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, 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
50383-311-07NDC Unit Dose Cup 50383-311-07
- Lot codes and dates
Lot 369409Exp. Date 05/2021Lot 372393Exp. Date 01/2022Lot 373112Exp. Date 04/2022
- Amount recalled
- 8,183 unit dose cups
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Akorn, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.