Recalls / Class II
Class IID-0053-2024
Product
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Affected lot / code info
- Lot #: 69802, Exp. Date 02/28/2024
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
- 128 bags
- 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-0053-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.