Drug Enforcement D-0084-2025

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Status

Ongoing

Classification

Class I

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.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
E-Mail
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-0084-2025
Event ID
95714
Recall initiation date
November 4, 2024
Center classification date
December 2, 2024
Code info
Lot #: 230811, Exp: 08/11/2025
More code info
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