FDA-Drug2016-10-19Class II
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Hospira Inc., A Pfizer Company
Hazard
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Sold states
Nationwide and Puerto Rico
Affected count
4768 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2017Don't want to check this manually?
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