Drug product
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
D-0412-2018
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 78969
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,770 bottles
- Official record key
drug-enforcement:D-0412-2018
Official wording
Reason: Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Code information: Lot #: 1088856, Exp 6/20
Distribution pattern: MS, OH
Derived failure modes
-
Unknown
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.