Why it was recalled
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Product description
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Lot numbers, UPCs & expiration codes
Lot #: 6010157, Exp. 01/2017
Where it was sold
Nationwide and Puerto Rico
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-0819-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 5, 2016
- FDA report date
- Apr 20, 2016
- Quantity
- 94,560 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0819-2016, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73751
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6010157, Exp. 01/2017
- Postal code
- 60047-8930
- Report date
- Apr 20, 2016
- Product type
- Drugs
- Recall number
- D-0819-2016
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 94,560 vials
- Termination date
- Apr 11, 2017
- Reason for recall
- Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 5, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2016