Calcium Gluconate Ophthalmic Irrigation Solution Recall Due to Sterility Concerns
Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall for a pharmaceutical product with lack of sterility assurance. While no illnesses or injuries have been reported, the product poses a significant risk of serious harm, including eye infections. Per the rubric, a risk-of-harm product without reported injury receives a score of 3.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags (Lot #69802, expiration date 02/28/2024) due to lack of assurance of sterility. The product is a compounded ophthalmic irrigation solution intended for eye use.
The 128 bags were distributed nationwide within the United States. Because the solution lacks assured sterility, it may be contaminated with microorganisms that could cause eye infections or other serious ocular complications if administered to patients.
Healthcare providers and patients who have received this product should discontinue use immediately. Anyone who has used this solution and develops symptoms such as eye inflammation, irritation, pain, or discharge should seek immediate medical attention.
The recalled product
- Product
- Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 128
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 #: 69802
- Exp. Date 02/28/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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