Class II
Terminated
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.
- Company
- Sagent Pharmaceuticals Inc
- Recall Initiated
- March 11, 2021
- Posted
- March 24, 2021
- Recall Number
- D-0305-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3716 cartons
- Firm Location
- Schaumburg, IL, United States
Reason for Recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
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