Drug product
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.
D-0286-2021
Product summary
- Event
- Event 87224
- Status
- Terminated
- Classification
- Class I
- Quantity
- 34,860 vials
- Official record key
drug-enforcement:D-0286-2021
Official wording
Reason: Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Code information: Lot C11507A
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
mislabeled