Status
Ongoing
Drug Enforcement D-0086-2025
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Classification
Class I
Report Date
December 11, 2024
Termination Date
—
Product Information
- Product description
- ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
- Product quantity
- Unknown
- Reason for recall
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Boulla LLC
- Address
-
2108 N ST #7929
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0086-2025
- Event ID
- 95714
- Recall initiation date
- November 4, 2024
- Center classification date
- December 2, 2024
- Code info
- Lot #: YZM240406, Exp: 04/05/2027
- More code info
- —