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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62543

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 16, 2012
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Coral Rock Man, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida

D-038-2013
Recall number
D-038-2013
Initiated
July 16, 2012
Classification
Class I
Status
Terminated
Recalling firm
Coral Rock Man, Inc.
Quantity
unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

Code information

All Lots All codes.

Distribution pattern

Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.

drug · product 2 of 2

Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066

D-039-2013
Recall number
D-039-2013
Initiated
July 16, 2012
Classification
Class I
Status
Terminated
Recalling firm
Coral Rock Man, Inc.
Quantity
unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

Code information

All Lots All codes.

Distribution pattern

Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.