D-0084-2025 Class I Ongoing
FDA drug recall D-0084-2025 was initiated by Boulla LLC on November 4, 2024 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. The recall status is ongoing. Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 230811, Exp: 08/11/2025