D-0058-2024 Class II Terminated
FDA drug recall D-0058-2024 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: 2176 syringes.
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
- 2176 syringes
Product Description
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, 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 #: 67623, Exp. Date 10/15/2023; 67919, Exp. Date 10/29/2023; 68917, Exp. Date 12/16/2023; 69079, Exp. Date 12/23/2023; 69120, Exp. Date 12/24/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0058-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026