Why it was recalled
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
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
Lot numbers, UPCs & expiration codes
Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0301-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 8,183 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0301-2021, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87462
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
- Postal code
- 60045-4862
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0301-2021
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 8,183 unit dose cups
- Termination date
- Aug 9, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Mar 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2021