Why it was recalled
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Product description
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Lot numbers, UPCs & expiration codes
Lot: 760853A
Where it was sold
United States Nationwide (including Puerto Rico) and Singapore
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-1167-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 115,370 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1167-2017, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77956
- Address
- 235 E 42nd St
- Code information
- Lot: 760853A
- Postal code
- 10017-5703
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1167-2017
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 115,370 vials
- Termination date
- Feb 19, 2023
- Reason for recall
- Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
- Distribution pattern
- United States Nationwide (including Puerto Rico) and Singapore
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2017