Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance
Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.
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 an injectable medication with lack of sterility assurance and no reported illnesses or injuries. This qualifies as a risk-of-harm product where potential for serious infection exists but injury has not yet been reported, per the severity rubric.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling compounded Foscarnet Sodium 2.4mg/0.1 mL solution for injection in single-dose Luer Slip syringes (Lot #68680, expiration 12/4/2023) nationwide due to lack of assurance of sterility. A total of 136 syringes are affected by this recall.
Foscarnet is an injectable antiviral medication used to treat certain viral infections. If the product lacks assurance of sterility, there is a potential risk that the solution may be contaminated, which could lead to serious infection in patients receiving the injection.
No illnesses or injuries have been reported in connection with this recall. Patients who received an injection from the recalled lot should contact their healthcare provider. Healthcare providers and pharmacies that dispensed this product should identify patients who may have received syringes from the affected lot and notify them accordingly.
The recalled product
- Product
- Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Injectable / Compounded
- Hazard
- lack-of-sterility
- infection-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 #: 68680
- Exp. Date 12/4/2023
Distribution
Distributed nationwide across the United States.
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