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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65948

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

Open FDA event record

Event summary

Timeline bucket
August 08, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Qualitest Pharmaceuticals

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

K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409

D-1036-2013
Recall number
D-1036-2013
Initiated
August 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Qualitest Pharmaceuticals
Quantity
1680 boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
LABELING: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

Code information

Lot Number 21230-2, Exp. DEC 2015

Distribution pattern

Natiowide

drug · product 2 of 2

EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409

D-1037-2013
Recall number
D-1037-2013
Initiated
August 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Qualitest Pharmaceuticals
Quantity
1680 boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
LABELING: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

Code information

Lot Number 21230-2, Exp. DEC 2015

Distribution pattern

Natiowide