Phenylephrine HCL PF INJ in 0 recalled over sterility concerns

Recall date

June 18, 2019

Source

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

Official notice title

Premier Pharmacy Labs Inc recalls Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syrin…

Recall number

D-1424-2019

FDA classification

Class II

Brand / firm

Premier Pharmacy Labs Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

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 HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.