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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88806

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

Open FDA event record

Event summary

Timeline bucket
October 12, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
SUN PHARMACEUTICAL INDUSTRIES INC

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

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

D-0068-2022
Recall number
D-0068-2022
Initiated
October 12, 2021
Classification
Class III
Status
Terminated
Quantity
22,752 blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Moisture Limits

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Moisture Limits

Code information

Lot #: AC14635, Exp. Date 12/2022

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

D-0069-2022
Recall number
D-0069-2022
Initiated
October 12, 2021
Classification
Class III
Status
Terminated
Quantity
46,584 blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Moisture Limits

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Moisture Limits

Code information

AC09723, Exo, Date 11/2022

Distribution pattern

Nationwide within the United States