FDA Recall D-1073-2019
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 684 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Recall record
- Recall number
D-1073-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- United States and Puerto Rico
- Recall initiated
- 2019-03-15
- Classified by FDA Center
- 2019-03-29
- FDA published
- 2019-04-10
- Terminated
- 2021-01-27
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY