Drug product
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
D-0084-2025
Product summary
- Firm
- Boulla LLC
- Event
- Event 95714
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0084-2025
Official wording
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Code information: Lot #: 230811, Exp: 08/11/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.