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.
Reported: March 3, 2021 Initiated: January 27, 2021 #D-0286-2021
Product Description
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.
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
Details
- Recalling Firm
- Meitheal Pharmaceuticals Inc
- Units Affected
- 34,860 vials
- Distribution
- Nationwide USA
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Meitheal Pharmaceuticals Inc. Units affected: 34,860 vials.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 3, 2021. Severity: Critical. Recall number: D-0286-2021.
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