D-0060-2024 Class II Terminated
FDA drug recall D-0060-2024 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: 1693 droppers.
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
- 1693 droppers
Product Description
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, 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 #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0060-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026