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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87648

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

Open FDA event record

Event summary

Timeline bucket
March 31, 2021
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Apotex Corp.

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

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

D-0324-2021
Recall number
D-0324-2021
Initiated
March 31, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Apotex Corp.
Quantity
55620 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Code information

Lot #: RX1662, RX1663, RX1664 Exp. 11/2022

Distribution pattern

Nationwide within the United States