D-0305-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- December 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3716 cartons
Product Description
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Reason for Recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022