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.

Reason: 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.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide in the USA