FDA recall D-0305-2021

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.

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

Key facts

Status

Terminated

Initiation date

2021-03-11

Report date

2021-03-24

Termination date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2021