Why it was recalled
Lack of Assurance of Sterility: Bag has the potential to leak.
Product description
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
Lot numbers, UPCs & expiration codes
Lot #: 87-095-JT Exp. 1MAR2020
Where it was sold
Nationwide in the 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-0136-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 17832 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0136-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83947
- Address
- 235 E 42nd St
- Code information
- Lot #: 87-095-JT Exp. 1MAR2020
- Postal code
- 10017-5703
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0136-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 17832 bags
- Termination date
- Dec 1, 2020
- Reason for recall
- Lack of Assurance of Sterility: Bag has the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
- Distribution pattern
- Nationwide in the United States and Puerto Rico
- Recall initiation date
- Oct 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019