Phenylephrine HCI Injection recalled over sterility concerns

Recall date

August 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz Inc recalls Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per…

Recall number

D-1514-2016

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.