Premier Pharmacy Labs Inc recalls Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Com
Recalled July 3, 2019 · FDA recall D-1418-2019 · Premier Pharmacy Labs
Hazard
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. · FDA Class II
Units
40 bags
Sold at
Nationwide in the USA
Description
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.
Product
Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.
Manufacturer(s)
Premier Pharmacy Labs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →