FDA-Drug2023-10-25Class II

Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
881 pre-filled syringes
Manufactured in
355 Riverwalk Pkwy, N/A, Tonawanda, NY, United States
Products
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2024

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