Endophth Kit Recalled Due to Lack of Sterility Assurance
Pine Pharmaceuticals recalled an Endophth Kit (Vancomycin/Ceftazidime injectable) distributed nationwide due to lack of assurance of sterility. The recall affects 201 kits from lot 69986 (expires 11/15/2023).
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 is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations, making it at most a score of 3 per the rubric. The hazard involves a high-risk injectable pharmaceutical where failure of sterility assurance poses a theoretical risk of microbial contamination, fitting the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pine Pharmaceuticals has issued a recall of Endophth Kit (containing Vancomycin 1mg/0.1 mL and Ceftazidime 2.25mg/0.1 mL), an injectable pharmaceutical product used for treating infections. The recall affects 201 kits that were distributed nationwide.
The manufacturer recalled the product due to lack of assurance of sterility. As an injectable product, sterile manufacturing is critical to patient safety.
The affected lot number is 69986 with an expiration date of 11/15/2023. If you have received or administered this product, contact your healthcare provider or Pine Pharmaceuticals for guidance regarding potential replacement or alternative therapies.
The recalled product
- Product
- Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- sterility-risk
- contamination-risk
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 #: 69986
- Exp. Date 11/15/2023
Distribution
Distributed nationwide across the United States.
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