FDA recall D-1424-2019

Premier Pharmacy Labs Inc · Class II · drug

Product

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 for recall

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-06-18
Report date
2019-07-03
Termination date
2021-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Weeki Wachee, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1424-2019