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.
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: 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
- Affected units
- 136
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.
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.
See all 16 products in this recall →Related recalls
Same manufacturer · Pine Pharmaceuticals, LLC
See all →- HighVancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-10-25
- HighFDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighTPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighCompounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance
FDA (Drugs) · 2023-10-25
- HighLidocaine eye drops recalled due to lack of sterility assurance
FDA (Drugs) · 2023-10-25
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighRocuronium Injectable Drug Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-09-06
- HighLidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect
FDA (Drugs) · 2022-11-09
- HighFDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2024-04-03
- SeverePremier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-07-03
- HighFentanyl Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighPhenylephrine Injectable Drug Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03