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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63224

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

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Event summary

Timeline bucket
September 20, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sandoz Incorporated

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

Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33

D-008-2013
Recall number
D-008-2013
Initiated
September 20, 2012
Classification
Class III
Status
Terminated
Recalling firm
Sandoz Incorporated
Quantity
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

Code information

NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.

Distribution pattern

Nationwide