Drug product
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
D-0071-2018
Product summary
- Event
- Event 78376
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 vials (25 mislabeled vials)
- Official record key
drug-enforcement:D-0071-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Code information: Lot # 64340EV, exp 07/2018 ACE ITEM # 1671018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing