Class I
Terminated
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.
This recall has been terminated (originally issued March 3, 2021).
- Company
- Meitheal Pharmaceuticals Inc
- Recall Initiated
- January 27, 2021
- Posted
- March 3, 2021
- Recall Number
- D-0286-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 34,860 vials
- Firm Location
- Chicago, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Nationwide USA
Lot / Code Info
Lot C11507A
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