Why it was recalled
Lack of assurance of sterility: Bags have the potential to leak.
Product description
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Lot numbers, UPCs & expiration codes
Lot: 5935283, Exp. 12/01/2023
Where it was sold
Nationwide in the USA.
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-0097-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Dec 29, 2022
- FDA report date
- Jan 11, 2023
- Quantity
- 62,088 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0097-2023, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 91379
- Address
- 235 East 42nd Street
- Code information
- Lot: 5935283, Exp. 12/01/2023
- Postal code
- 10017-5703
- Report date
- Jan 11, 2023
- Product type
- Drugs
- Recall number
- D-0097-2023
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 62,088 bags
- Reason for recall
- Lack of assurance of sterility: Bags have the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2023