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.

Recall Number: D-1424-2019

Firm: Premier Pharmacy Labs Inc

Classification: Class II

Status: Terminated

Report Date: 20190703

Initiation Date: 20190618

Termination Date: 20211026

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.

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.