Premier Pharmacy Labs Inc recalls SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 C
Recalled July 3, 2019 · FDA recall D-1428-2019 · 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
1721 syringes
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
SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
Manufacturer(s)
Premier Pharmacy Labs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →