PlainRecalls
FDA Drug Moderate Class II Terminated

Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1078-2022

Product Description

Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
564 cartons/25 vials each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 564 cartons/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-1078-2022.