Recalls / Class II
Class IID-0057-2024
Product
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Affected lot / code info
- Lot #: 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 355 Riverwalk Pkwy, N/A, Tonawanda, New York 14150-5837
Distribution
- Quantity
- 4972 syringes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-10-02
- FDA classified
- 2023-10-19
- Posted by FDA
- 2023-10-25
- Terminated
- 2024-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0057-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.