Drug recall: Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated…

Class III FDA enforcement event 70334. Recall start date: 2 Oct 2013. Status in the FDA record: Terminated. Termination date: 30 Sep 2015.

Reason for recall, in the words of FDA

Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Cardinal Health started this drug recall on 2 Oct 2013. The firm address in the FDA record is in Zanesville, OH. FDA put the recall in Class III. FDA event 70334 has 1 product record. The first FDA enforcement report date is 22 Apr 2015. The record gives the status Terminated, with the termination date 30 Sep 2015.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

OK

Recalling firm

Cardinal Health, Zanesville, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 70334: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0489-2015	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701	100 blister cards	Class III	Terminated	22 Apr 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2013: 370
Share of these events in Class III: 26%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Cardinal Health
Initiated	Product (first record)	Type	Class	Records
1 Nov 2022	Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary dr	Device	Class II	6
2 Nov 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474	Device	Class II	11
4 Aug 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicat	Device	Class I	3
11 Jan 2020	AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA	Device	Class II	39
20 Jul 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste	Device	Class II	1
27 Jun 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me	Device	Class II	1
29 Feb 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of	Device	Class II	1
25 Aug 2015	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for m	Device	Class II	1
23 Dec 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us	Device	Class II	1
18 Dec 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.	Device	Class II	9

Cardinal Health: all 12 events

Official channels

FDA enforcement report D-0489-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 70334. https://recallregister.com/fda/iii/70334/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: OK
What quantity of product is in FDA event 70334?: The FDA record gives this quantity: 100 blister cards
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2013 have the same class?: 26% of the 370 drug events that started in 2013 are in Class III.