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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84864

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

Open FDA event record

Event summary

Timeline bucket
January 31, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Efficient Laboratories, 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

3 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 3

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

D-0845-2020
Recall number
D-0845-2020
Initiated
January 31, 2020
Classification
Class II
Status
Terminated
Quantity
5249 6 Fl Oz bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

Lot: 19H359 Exp. August 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 3

Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1

D-0846-2020
Recall number
D-0846-2020
Initiated
January 31, 2020
Classification
Class II
Status
Terminated
Quantity
5387 6 Fl Oz bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

Lot: 19F332 Exp. June 2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 3

New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

D-0847-2020
Recall number
D-0847-2020
Initiated
January 31, 2020
Classification
Class II
Status
Terminated
Quantity
4080 8 FL Oz bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

Lot: 19B42 Exp. February 2022

Distribution pattern

Distributed Nationwide in the USA