PROPOFOL Recall D-1301-2022
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
PROPOFOL Recall D-1301-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1301-2022 |
Event ID | 90581 |
Brand | PROPOFOL |
Generic Name | PROPOFOL |
Manufacturer | PROPOFOL |
Original Package? | 1 |
Active Substance | PROPOFOL |
Drug Route | INTRAVENOUS |
Distribution | USA Nationwide |
Quantity | 54,000 vials |
Recall Reason | Presence of particulate matter: particulate identified as a beetle. |
Drug Classification | Class I |
Drug Code Info | 20220803 |
Product NDC | 0409-4699 0409-6010 |
Product NUI | N0000175975 N0000175681 |
Pharma Class (PE) | General Anesthesia [PE] |
Pharma Class (EPC) | General Anesthetic [EPC] |
Recall Initiation Date | 20220713 |
Report Date | 20220803 |
Classification Date | 20220803 |
Address | 235 East 42nd Street New York, NY 10017-5703 United States |
Recalling Firm | Pfizer Inc. |
Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
Unique Ingredient Identifier | YI7VU623SF |
Drug Application Number | ANDA077908 |
Structured Product Labeling (SPL ID) | efa079a1-3089-4139-a288-6f25e860bd0e |
Structured Product Labeling (SPL Set ID) | 28d7ba00-f824-4e55-139a-03f509c099db |
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