Why it was recalled
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Product description
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Lot numbers, UPCs & expiration codes
Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.
Where it was sold
Nationwide in the USA 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-1023-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 28, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 234,680 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PFIZER
Original FDA data
Every field from FDA enforcement report D-1023-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80399
- Address
- 275 N Field Dr
- Code information
- Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.
- Postal code
- 60045-2579
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1023-2018
- Classification
- Class II
- Recalling firm
- PFIZER
- Product quantity
- 234,680 vials
- Termination date
- Aug 25, 2022
- Reason for recall
- Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Jun 28, 2018
- Initial firm notification
- Press Release
- Center classification date
- Aug 2, 2018