D-0052-2024 Class II Terminated

Recalled by Pine Pharmaceuticals, LLC — Tonawanda, NY

FDA drug recall D-0052-2024 was initiated by Pine Pharmaceuticals, LLC on Oct 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: 201 kits.

Recall Details

Product Type
Drugs
Report Date
Oct 25, 2023
Initiation Date
Oct 2, 2023
Termination Date
May 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
201 kits

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 69986, Exp. Date 11/15/2023

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0052-2024
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0052-2024. Report a data issue: hello@regdatalab.com.