D-0051-2024 Class II Terminated

Recalled by Pine Pharmaceuticals, LLC — Tonawanda, NY

FDA drug recall D-0051-2024 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: 26 vials.

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
26 vials

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 69985, exp. date 11/15/2023