Recalls / Class I
Class ID-0286-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Cisatracurium Besylate
- Generic name
- Cisatracurium Besylate
- Active ingredient
- Cisatracurium Besylate
- Route
- Intravenous
- NDCs
- 71288-712, 71288-714, 71288-713
- FDA application
- ANDA211668
- Affected lot / code info
- Lot C11507A
Why it was 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
Recalling firm
- Firm
- Meitheal Pharmaceuticals Inc
- Manufacturer
- Meitheal Pharmaceuticals Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 8700 W Bryn Mawr Ave Ste 600, N/A, Chicago, Illinois 60631-3512
Distribution
- Quantity
- 34,860 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-01-27
- FDA classified
- 2021-02-22
- Posted by FDA
- 2021-03-03
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0286-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.