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
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.
Lot numbers, UPCs & expiration codes
Lot C11507A
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0286-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 27, 2021
- FDA report date
- Mar 3, 2021
- Quantity
- 34,860 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meitheal Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0286-2021, exactly as published.
Show all FDA fields
- City
- Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87224
- Address
- 8700 W Bryn Mawr Ave Ste 600
- Code information
- Lot C11507A
- Postal code
- 60631-3512
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0286-2021
- Classification
- Class I
- Recalling firm
- Meitheal Pharmaceuticals Inc
- Product quantity
- 34,860 vials
- Termination date
- Oct 16, 2023
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jan 27, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 22, 2021