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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61948

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

Open FDA event record

Event summary

Timeline bucket
April 26, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bayer Healthcare, 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

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

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24

D-1423-2012
Recall number
D-1423-2012
Initiated
April 26, 2012
Classification
Class III
Status
Terminated
Recalling firm
Bayer Healthcare, LLC
Quantity
119,412 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Code information

NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13

Distribution pattern

Product was distributed to 93 retail accounts/customers.

drug · product 2 of 2

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)

D-1424-2012
Recall number
D-1424-2012
Initiated
April 26, 2012
Classification
Class III
Status
Terminated
Recalling firm
Bayer Healthcare, LLC
Quantity
48,528 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Code information

NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13

Distribution pattern

Product was distributed to 93 retail accounts/customers.