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Nephron Sterile Compounding Center LLC recalls Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Inje

Recalled July 27, 2022 · FDA recall D-1278-2022 · Nephron Sterile Compounding Center

Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2210 syringes
Sold at
Nationwide in the USA

Description

Lack of Assurance of Sterility

Product
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50
Manufacturer(s)
Nephron Sterile Compounding Center LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Nephron Sterile Compounding Center LLC recalls Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Inje | RecallWatchUSA