D-1073-2019 Class I Terminated
FDA drug recall D-1073-2019 was initiated by Pfizer Inc. on March 15, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter; glass particulates The recall status is terminated (terminated January 27, 2021). Affected quantity: 283,400 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2019
- Initiation Date
- March 15, 2019
- Termination Date
- January 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283,400 vials
Product Description
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Reason for Recall
Presence of Particulate Matter; glass particulates
Distribution Pattern
United States and Puerto Rico
Code Information
Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019