FDA-Drug2022-06-15Class II

Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA

Mckesson Medical-Surgical Inc. Corporate Office
Hazard

cGMP deviations: Temperature abuse

Sold states
USA nationwide.
Affected count
31 cartons/10 & 25 vials each
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2022

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