D-0065-2024 Class II Terminated

Recalled by Pine Pharmaceuticals, LLC — Tonawanda, NY

FDA drug recall D-0065-2024 was initiated by Pine Pharmaceuticals, LLC on October 2, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated May 15, 2024). Affected quantity: 136 syringes.

Recall Details

Product Type
Drugs
Report Date
October 25, 2023
Initiation Date
October 2, 2023
Termination Date
May 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
136 syringes

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 68680, Exp. Date 12/4/2023