Why it was recalled
Presence of Particulate Matter; glass particulates
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
Lot numbers, UPCs & expiration codes
Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019
Where it was sold
United States and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1073-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 15, 2019
- FDA report date
- Apr 10, 2019
- Quantity
- 283,400 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1073-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82362
- Address
- 235 E 42nd St
- Code information
- Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019
- Postal code
- 10017-5703
- Report date
- Apr 10, 2019
- Product type
- Drugs
- Recall number
- D-1073-2019
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 283,400 vials
- Termination date
- Jan 27, 2021
- Reason for recall
- Presence of Particulate Matter; glass particulates
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States and Puerto Rico
- Recall initiation date
- Mar 15, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 29, 2019