Why it was recalled
Lack of assurance of sterility.
Product description
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
Lot numbers, UPCs & expiration codes
Lot # 11092313110#01, Exp 01/12/24
Where it was sold
Philadelphia, Pennsylvania.
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-0141-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Nov 22, 2023
- FDA report date
- Dec 13, 2023
- Quantity
- 825 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wells Pharma of Houston LLC
Original FDA data
Every field from FDA enforcement report D-0141-2024, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Completed
- Country
- United States
- Event ID
- 93496
- Address
- 9265 Kirby Dr
- Code information
- Lot # 11092313110#01, Exp 01/12/24
- Postal code
- 77054-2520
- Report date
- Dec 13, 2023
- Product type
- Drugs
- Recall number
- D-0141-2024
- Classification
- Class II
- Recalling firm
- Wells Pharma of Houston LLC
- Product quantity
- 825 syringes
- Reason for recall
- Lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
- Distribution pattern
- Philadelphia, Pennsylvania.
- Recall initiation date
- Nov 22, 2023
- Initial firm notification
- Telephone
- Center classification date
- Dec 6, 2023