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
Reported: March 24, 2021 Initiated: March 8, 2021 #D-0301-2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 8,183 unit dose cups
- Distribution
- Nationwide USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 8,183 unit dose cups.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Moderate. Recall number: D-0301-2021.
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