Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Lot numbers, UPCs & expiration codes
Lot #: 6018699, Exp. 12/2021
Where it was sold
Nationwide within the United States
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-1386-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 22, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 11,981 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1386-2019, exactly as published.
Show all FDA fields
- City
- Grand Island
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82915
- Address
- 3159 Staley Rd
- Code information
- Lot #: 6018699, Exp. 12/2021
- Postal code
- 14072-2028
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1386-2019
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 11,981 units
- Termination date
- Jan 28, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 22, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2019