Pine Pharmaceuticals recalls 5mL pre-filled syringes of Calcium Gluconate 2.5% solution for inhalation due to lack of sterility assurance. This Rx-only product was compounded by Pine Pharmaceuticals in Tonawanda, NY.
Lack of Assurance of Sterility
Pine Pharmaceuticals is recalling 5mL pre-filled syringes of Calcium Gluconate 2.5% solution for inhalation because they may not be sterile. This is a serious risk as unsterile solutions can cause infections when inhaled.
The solution may not be sterile, meaning it could contain harmful bacteria or other contaminants. When inhaled, this can lead to serious infections or other health complications in the respiratory system.
Prescription patients who received this specific product from Pine Pharmaceuticals. Those with respiratory conditions are at higher risk due to inhalation use.
Check for the product name 'Calcium Gluconate 2.5% solution for inhalation', 5mL pre-filled syringes, and the lot number 70363 with an expiration date of March 20, 2024.
Immediately discard the recalled syringes as they may not be sterile and could cause infection if inhaled.
No, the product may not be sterile and could cause infection if inhaled. Do not use.
The expiration date is March 20, 2024.
Look for the product name 'Calcium Gluconate 2.5% solution for inhalation', 5mL pre-filled syringes, and the lot number 70363 with an expiration date of March 20, 2024.
We’ve drafted a message you can send Pine Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0054-2024 — Pine Pharmaceuticals Pine Pharmaceuticals Hello, I own a Pine Pharmaceuticals that is covered by recall D-0054-2024 from Pine Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
