D-0059-2024 Class II Terminated
FDA drug recall D-0059-2024 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: 9673 vials.
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
- 9673 vials
Product Description
Lidocaine-phenylephrine 1%-1.5% 1mL 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 #: 67849, Exp. Date 10/25/2023; 67887, Exp. Date 10/28/2023; 68260, Exp. Date 11/14/2023; 68534, Exp. Date 11/27/2023; 68816, Exp. Date 12/12/2023; 69046, Exp. Date 12/20/2023; 69971, Exp. Date 1/13/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0059-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026