Vancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure
Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.
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: This FDA Class II recall affects a high-risk product for direct eye injection. Lack of sterility assurance in an intraocular drug poses risk of serious infection. No illnesses or injuries have been reported, so the hazard remains theoretical; per the rubric, such cases score at most 3.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling 26 vials of Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML single-dose vials. The affected lot is Lot #69985 with an expiration date of 11/15/2023.
The recall is due to a lack of assurance of sterility. Because this product is injected directly into the eye, sterility is essential to prevent infection. The manufacturer cannot guarantee that the product meets sterility requirements.
The affected vials were distributed nationwide within the United States. Healthcare facilities and pharmacies that have this product should identify and quarantine the recalled lot.
Patients who received an injection from this lot should contact their healthcare provider. Healthcare providers should discontinue use of the product and notify patients of the recall if applicable. Any adverse events should be reported to the FDA or Pine Pharmaceuticals.
The recalled product
- Product
- Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Hazard
- lack-of-sterility
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 #: 69985
- exp. date 11/15/2023
Distribution
Distributed nationwide across the United States.
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