Why it was recalled
Lack of Assurance of Sterility: Bags have the potential to leak.
Product description
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
Lot numbers, UPCs & expiration codes
Lot #s: 85-516-KL; 85-517-KL, Exp. 1JAN2020; 86-601-KL; 86-603-KL; 86-618-KL, Exp. 1FEB2020; 87-707-KL, Exp. 1MAR2020; 91-205-KL, Exp. 1JUL2020; 92-306-KL, Exp. 1AUG2020.
Where it was sold
United States, PR, and Guam
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-1487-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 9, 2019
- FDA report date
- Jul 24, 2019
- Quantity
- 280340 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1487-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83267
- Address
- 235 E 42nd St
- Code information
- Lot #s: 85-516-KL; 85-517-KL, Exp. 1JAN2020; 86-601-KL; 86-603-KL; 86-618-KL, Exp. 1FEB2020; 87-707-KL, Exp. 1MAR2020; 91-205-KL, Exp. 1JUL2020; 92-306-KL, Exp. 1AUG2020.
- Postal code
- 10017-5703
- Report date
- Jul 24, 2019
- Product type
- Drugs
- Recall number
- D-1487-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 280340 bags
- Termination date
- Oct 27, 2021
- Reason for recall
- Lack of Assurance of Sterility: Bags have the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
- Distribution pattern
- United States, PR, and Guam
- Recall initiation date
- Jul 9, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2019