Why it was recalled
Lack of sterility assurance: bag has the potential to leak.
Product description
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Lot numbers, UPCs & expiration codes
Lot: 4923608 Exp. 1MAY2022
Where it was sold
USA Nationwide
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-0265-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 30, 2021
- FDA report date
- Dec 8, 2021
- Quantity
- 765 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0265-2022, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89100
- Address
- 235 East 42nd Street
- Code information
- Lot: 4923608 Exp. 1MAY2022
- Postal code
- 10017-5703
- Report date
- Dec 8, 2021
- Product type
- Drugs
- Recall number
- D-0265-2022
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 765 bags
- Termination date
- Jul 12, 2023
- Reason for recall
- Lack of sterility assurance: bag has the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Nov 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2021