Why it was recalled
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Product description
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Lot numbers, UPCs & expiration codes
Lot #: 1088856, Exp 6/20
Where it was sold
MS, OH
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-0412-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 22, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- 7,770 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc.
Original FDA data
Every field from FDA enforcement report D-0412-2018, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78969
- Address
- 1 N Waukegan Rd
- Code information
- Lot #: 1088856, Exp 6/20
- Postal code
- 60064-1802
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0412-2018
- Classification
- Class III
- Recalling firm
- AbbVie Inc.
- Product quantity
- 7,770 bottles
- Termination date
- Sep 13, 2018
- Reason for recall
- Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
- Distribution pattern
- MS, OH
- Recall initiation date
- Jan 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2018