Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile inhalation product with no reported illnesses or injuries. The hazard involves potential sterility failure in a critical care product, classified as a risk-of-harm scenario without confirmed injury per the rubric.
Plain-English summary
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% solution for inhalation across the United States. The recall affects 881 pre-filled syringes from lot #70363 with an expiration date of March 20, 2024. This is a prescription-only product compounded by Pine Pharmaceuticals.
The recall was initiated due to a lack of assurance of sterility for the affected product. Inhalation medications must meet strict sterility standards to prevent infection when delivered directly to the lungs.
Healthcare providers and patients who have this product should stop using it immediately. Patients should contact their healthcare provider or pharmacy to discuss this recall and alternative treatment options. Do not use any syringes from lot #70363.
The recalled product
- Product
- Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Hazard
- sterility-assurance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 70363
- Exp. Date 03/20/2024
Distribution
Distributed nationwide across the United States.
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