FDA Recall of Potassium Capsules - MedWaste Management FDA Recall of Potassium Capsules - MedWaste Management

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FDA Recall Potassium Chloride K+ Extended Release

FDA Recall of Potassium Capsules

The FDA has announced a recall of extended-release Potassium Chloride capsules due to a failure to dissolve as intended. When functioning properly, the drug is slowly released into the patient’s system, allowing for proper processing. However, failure of the dissolution process may lead to sudden release of the entirety of the capsule, causing severe and dangerous health outcomes.

As of the writing of this notice, the FDA has not announced any adverse events related to the contamination.

SUMMARY

Date of Recall:

Announced: June 24, 2024

Public Notification: June 25, 2024

Name(s) of Drug:

Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEq K

Company Name:

Glenmark Pharmaceuticals, Inc.

Drug Indication:

Potassium Supplementation

FDA Recall Potassium Chloride K+ Extended Release Package
FDA Recall Potassium Chloride K+ Extended Release Package

Product Description

Potassium Chloride Extended-Release Capsules are available by prescription only. Pharmacies nationwide distributed the capsules to the facility and consumer levels. Each was packaged in either 100-count or 500-count bottles and labeled clearly with an orange and white label. The NDC number, expiration date, batch number, and product name are clearly printed on the package.

Reason for Recall

Glenmark Pharmaceuticals, Inc., is voluntarily initiating the recall. They have not publicly stated how the failed dissolution was discovered, but the FDA report states that no serious adverse events have been reported as a result of the failure.

Impacts

Consumers who continue to use the faulty drug may experience serious health outcomes related to a sudden increase in their potassium levels. High potassium levels may lead to effects such as:

  • Irregular heartbeat
  • Cardiac arrest (heart attack)
  • Severe muscle weakness
  • Death

Recall Lot Information

All medical facilities and distributors who stock Potassium Chloride Capsules and consumers who take the capsules must carefully examine their inventory to determine if their product is included in the recall. Compare each bottle’s NDC and lot numbers, strength, and expiration date to the chart below. If any are found to match, read further for instructions on participating in the recall.

Sr. NoNDCProduct NameBatch No.Expiry Date
1.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221393Jun-24
2.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221403Jun-24
3.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221405Jun-24
4.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221503Jun-24
5.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221508Jun-24
6.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221567Jul-24
7.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221566Jul-24
8.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221719Jul-24
9.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221731Jul-24
10.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221891Aug-24
11.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221892Aug-24
12.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221900Aug-24
13.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17221992Aug-24
14.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222022Aug-24
15.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222056Sep-24
16.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222043Sep-24
17.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222068Sep-24
18.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222079Sep-24
19.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222099Sep-24
20.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222103Sep-24
21.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222114Sep-24
22.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222119Sep-24
23.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222188Sep-24
24.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222199Sep-24
25.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222209Sep-24
26.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222200Sep-24
27.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222265Oct-24
28.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222269Oct-24
29.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222527Nov-24
30.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222530Nov-24
31.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222583Nov-24
32.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17222586Nov-24
33.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230051Nov-24
34.68462-357-01Potassium Chloride Extended-Release Capsules USP17230075Nov-24
35.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230067Nov-24
36.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221489Jun-24
37.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221504Jun-24
38.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221530Jun-24
39.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221561Jul-24
40.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221579Jul-24
41.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221568Jul-24
42.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221702Jul-24
43.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221704Jul-24
44.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221898Aug-24
45.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17221993Aug-24
46.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222029Aug-24
47.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222300Oct-24
48.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222304Oct-24
49.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222278Oct-24
50.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222609Oct-24
51.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222395Oct-24
52.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222589Nov-24
53.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222605Nov-24
54.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17222613Nov-24
55.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230074Dec -24
56.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230221Dec -24
57.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230468Jan-25
58.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230479Jan-25
59.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230553Jan-25
60.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230543Jan-25
61.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230561Jan-25
62.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230619Feb-25
63.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230624Feb -25
64.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230879Mar -25
65.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230890Mar -25
66.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230918Mar -25
67.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230984Mar -25
68.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17230996Mar-25
69.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231002Mar-25
70.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231081Mar-25
71.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231102Apr-25
72.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231135Apr-25
73.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231329Apr-25
74.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231369May-25
75.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231513May-25
76.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231516Jun-25
77.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231713Jun-25
78.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231909Jul -25
79.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231903Jul -25
80.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17231943Aug-25
81.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17232166Sep -25
82.68462-357-01Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 100 count17232179Sep -25
83.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230186Dec-24
84.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230192Dec-24
85.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230213Dec-24
86.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230278Dec-24
87.68462-357-05Potassium Chloride Extended-Release Capsules USP17230399Dec-24
88.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230406Jan-25
89.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230412Jan-25
90.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230427Jan-25
91.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230444Jan-25
92.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230453Jan-25
93.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230495Jan-25
94.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230574Feb-25
95.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230585Feb-25
96.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230608Feb-25
97.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230629Feb – 25
98.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230883Mar -25
99.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17230921Mar -25
100.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231087Apr- 25
101.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231339Apr-25
102.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231360May-25
103.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231711Jun-25
104.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231745Jun-25
105.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231819Jul-25
106.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231820Jul-25
107.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231936Jul-25
108.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231957Jul-25
109.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17231998Aug-25
110.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17232012Aug-25
111.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17232110Sep- 25
112.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17232114Aug-25
113.68462-357-05Potassium Chloride Extended-Release Capsules USP17232119Sep- 25
114.68462-357-05Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEQ K  – 500 count17232343Sep-25

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumer Recall Instructions

If you find that your lot of medication is part of this recall, do the following:

  1. Do not take the recalled medication.
  2. Ask your doctor to replace the recalled drug with a new bottle. If the lot number, NDC number, and expiration date do not match the chart, the medication is not included in this recall.
  3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

Healthcare System Recall Instructions

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact Inmar RX Solutions at 1-877-883-9273. They are available from 9 a.m. to 5 p.m. EST, Monday through Friday.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler/Retailer Recall Instructions

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. If you have questions, contact Inmar RX Solutions at 1-877-883-9273. They are available from 9 a.m. to 5 p.m. EST, Monday through Friday. Notify them of any recalled batches that have already been shipped to medical facilities or been distributed to consumers.
  3. Notify affected medical facilities and consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

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