FDA Recall D-0286-2021
Meitheal Pharmaceuticals Inc · Chicago, IL
Class I — life-threatening Terminated 992 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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
Recall record
- Recall number
D-0286-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide USA
- Recall initiated
- 2021-01-27
- Classified by FDA Center
- 2021-02-22
- FDA published
- 2021-03-03
- Terminated
- 2023-10-16
- Recalling firm
- Meitheal Pharmaceuticals Inc
- Firm location
- Chicago, IL
Drug identification
- Brand name(s)
- CISATRACURIUM BESYLATE
- Generic name(s)
- CISATRACURIUM BESYLATE
- Manufacturer(s)
- Meitheal Pharmaceuticals Inc.
- NDC(s)
71288-712, 71288-714, 71288-713- Route(s)
- INTRAVENOUS