D-1301-2022 Class I Terminated
FDA drug recall D-1301-2022 was initiated by Pfizer Inc. on July 13, 2022 and is designated Class I. Reason for recall: Presence of particulate matter: particulate identified as a beetle. The recall status is terminated (terminated May 13, 2024). Affected quantity: 54,000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 3, 2022
- Initiation Date
- July 13, 2022
- Termination Date
- May 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,000 vials
Product Description
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Reason for Recall
Presence of particulate matter: particulate identified as a beetle.
Distribution Pattern
USA Nationwide
Code Information
Lot #: DX9067, Exp 5/1/2023