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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76443

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

Open FDA event record

Event summary

Timeline bucket
February 13, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
L. Perrigo Company

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

Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.

D-0503-2017
Recall number
D-0503-2017
Initiated
February 13, 2017
Classification
Class III
Status
Terminated
Recalling firm
L. Perrigo Company
Quantity
10,656 units total for both products

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

Code information

Lot #: 099534, Exp. 07/18; 099512 Exp. 06/18.

Distribution pattern

Nationwide within United States

drug · product 2 of 2

Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.

D-0504-2017
Recall number
D-0504-2017
Initiated
February 13, 2017
Classification
Class III
Status
Terminated
Recalling firm
L. Perrigo Company
Quantity
10,656 units total for both products

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

Code information

Lot #: 098840, 098779, Exp.06/18.

Distribution pattern

Nationwide within United States