D-0054-2024 Class II Terminated
FDA drug recall D-0054-2024 was initiated by Pine Pharmaceuticals, LLC on October 2, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated May 15, 2024). Affected quantity: 881 pre-filled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 25, 2023
- Initiation Date
- October 2, 2023
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 881 pre-filled syringes
Product Description
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 70363, Exp. Date 03/20/2024