Why it was recalled
Labeling: Incorrect or Missing Lot and/or expiration date.
Product description
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Lot numbers, UPCs & expiration codes
Lot #: 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
Where it was sold
Nationwide within the United States including 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-0577-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 27, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- 77,100 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0577-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84366
- Address
- 235 E 42nd St
- Code information
- Lot #: 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
- Postal code
- 10017-5703
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0577-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 77,100 syringes
- Termination date
- Jan 14, 2022
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or expiration date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
- Distribution pattern
- Nationwide within the United States including Puerto Rico.
- Recall initiation date
- Nov 27, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2019