D-1077-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- November 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 cartons/10 & 25 vials each
Product Description
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
Reason for Recall
cGMP deviations: Temperature abuse
Distribution Pattern
USA nationwide.
Code Information
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.