Why it was recalled
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Product description
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
Lot numbers, UPCs & expiration codes
Lot: 63-075-DK Exp. FEB 2019
Where it was sold
Nationwide in the USA
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-1177-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 1, 2017
- FDA report date
- Oct 4, 2017
- Quantity
- 18,725 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1177-2017, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78048
- Address
- 235 E 42nd St
- Code information
- Lot: 63-075-DK Exp. FEB 2019
- Postal code
- 10017-5703
- Report date
- Oct 4, 2017
- Product type
- Drugs
- Recall number
- D-1177-2017
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 18,725 vials
- Termination date
- Jan 24, 2020
- Reason for recall
- Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 1, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2017