Exact FDA event identifier

Event 83835

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 18, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: GCP 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30

D-0126-2020

Recall number: D-0126-2020
Initiated: September 18, 2019
Classification: Class II
Status: Terminated
Recalling firm: GCP Laboratories Inc
Quantity: 31,392 30 mL 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 Product.

Code information

Lot: WBD003 Exp. 03/21

Distribution pattern

Distributed in MI and further distributed Nationwide.