Why it was recalled
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Product description
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Lot numbers, UPCs & expiration codes
Lot #: ZG603, Exp 11/18
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-0426-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 16, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- 35,620 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0426-2018, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78949
- Address
- 3 Corporate Dr
- Code information
- Lot #: ZG603, Exp 11/18
- Postal code
- 60047-8930
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0426-2018
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 35,620 vials
- Termination date
- Sep 17, 2019
- Reason for recall
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jan 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2018