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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74135

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

Open FDA event record

Event summary

Timeline bucket
May 11, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Profarma Distributors LLC

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

5 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 5

tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

D-1039-2016
Recall number
D-1039-2016
Initiated
May 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Profarma Distributors LLC
Quantity
42 boxes (504 capsules)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # 224TS; Exp. 02/17

Distribution pattern

Nationwide

drug · product 2 of 5

tabcin NOCHE; Capsules,12-count box, UPC 501008485033

D-1040-2016
Recall number
D-1040-2016
Initiated
May 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Profarma Distributors LLC
Quantity
31 boxes ( 372 capsules)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # X223FS; Exp. 11/17

Distribution pattern

Nationwide

drug · product 3 of 5

VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619

D-1041-2016
Recall number
D-1041-2016
Initiated
May 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Profarma Distributors LLC
Quantity
163 boxes (978 tablets)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # UPE187; Exp. 08/17

Distribution pattern

Nationwide

drug · product 4 of 5

VERMOX Tablets 500 mg, 1-count box, UPC 501109900596

D-1042-2016
Recall number
D-1042-2016
Initiated
May 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Profarma Distributors LLC
Quantity
254 boxes (254 tablets)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # UJE 040; Exp. 02/17

Distribution pattern

Nationwide

drug · product 5 of 5

1% Clotrimazol cream, 30 mg tube, UPC 501318644335

D-1043-2016
Recall number
D-1043-2016
Initiated
May 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Profarma Distributors LLC
Quantity
79 boxes (79 tubes)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # GRU1390; Exp. 08/17

Distribution pattern

Nationwide