FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1077-2022

Product Description

Reason for Recall

cGMP deviations: Temperature abuse

Details

Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Units Affected: 31 cartons/10 & 25 vials each
Distribution: USA nationwide.
Location: Richmond, VA

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 31 cartons/10 & 25 vials each.

Why was this product recalled? ▼

cGMP deviations: Temperature abuse

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1077-2022.