D-0554-2025 Class II Ongoing
FDA drug recall D-0554-2025 was initiated by AEQUITA PHARMACY on July 18, 2025 and is designated Class II. Reason for recall: Lack of Processing Controls. The recall status is ongoing. Affected quantity: 236 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 vials
Product Description
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason for Recall
Lack of Processing Controls.
Distribution Pattern
MA
Code Information
All Lots within expiry