Drug product
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.
D-0305-2021
Product summary
- Event
- Event 87492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3716 cartons
- Official record key
drug-enforcement:D-0305-2021
Official wording
Reason: Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Code information: Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility