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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64388

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

Open FDA event record

Event summary

Timeline bucket
February 18, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
L. Perrigo Co.

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

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

PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716

D-216-2013
Recall number
D-216-2013
Initiated
February 18, 2013
Classification
Class III
Status
Terminated
Recalling firm
L. Perrigo Co.
Quantity
60,048 Blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.

Code information

2 AE1549 Exp. 02/13

Distribution pattern

Walmart Distribution Center in Bentonville, AR