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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89214

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

Open FDA event record

Event summary

Timeline bucket
November 29, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ULTRAtab Laboratories, 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

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

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

D-0327-2022
Recall number
D-0327-2022
Initiated
November 29, 2021
Classification
Class II
Status
Terminated
Quantity
14 bulk lots (approximately 1,987,951 tablets each)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Code information

Bulk Lots: 18K070, exp. date Nov-21; 19A046, exp. date Jan-22; 19C073, exp. date Mar-22; 19E014, exp. date May-22; 19G039, exp. date Jul-22; 19K002, exp. date Nov-22; 20A013, exp. date Jan-23; 20B050, exp. date Feb-23; 20C011, exp. date Mar-23; 20C049, exp. date Mar-23; 20F071, exp. date Jun-23; 20F072, exp. date Jun-23; 20G033, exp. date Jul-23; 20G041, exp. date Jul-23.

Distribution pattern

Product was distributed to one customer who may have further distributed the product.