Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due To Failed Dissolution

Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due To Failed Dissolution

MAHWAH, N.J. , June 25, 2024 /PRNewswire/ — Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Risk Statement: The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules.

The Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.

The recall includes the lot numbers and expiration dates listed below:

Sr. No

NDC

Product Name

Batch No.

Expiry Date

1.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221393

Jun-24

2.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221403

Jun-24

3.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221405

Jun-24

4.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221503

Jun-24

5.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221508

Jun-24

6.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221567

Jul-24

7.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221566

Jul-24

8.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221719

Jul-24

9.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221731

Jul-24

10.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221891

Aug-24

11.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221892

Aug-24

12.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221900

Aug-24

13.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17221992

Aug-24

14.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222022

Aug-24

15.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222056

Sep-24

16.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222043

Sep-24

17.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222068

Sep-24

18.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222079

Sep-24

19.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222099

Sep-24

20.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222103

Sep-24

21.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222114

Sep-24

22.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222119

Sep-24

23.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222188

Sep-24

24.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222199

Sep-24

25.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222209

Sep-24

26.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222200

Sep-24

27.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222265

Oct-24

28.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222269

Oct-24

29.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222527

Nov-24

30.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222530

Nov-24

31.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222583

Nov-24

32.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17222586

Nov-24

33.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230051

Nov-24

34.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230075

Nov-24

35.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230067

Nov-24

36.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221489

Jun-24

37.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221504

Jun-24

38.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221530

Jun-24

39.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221561

Jul-24

40.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221579

Jul-24

41.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221568

Jul-24

42.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221702

Jul-24

43.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221704

Jul-24

44.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221898

Aug-24

45.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17221993

Aug-24

46.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222029

Aug-24

47.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222300

Oct-24

48.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222304

Oct-24

49.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222278

Oct-24

50.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222609

Oct-24

51.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222395

Oct-24

52.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222589

Nov-24

53.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222605

Nov-24

54.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17222613

Nov-24

55.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230074

Dec -24

56.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230221

Dec -24

57.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230468

Jan-25

58.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230479

Jan-25

59.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230553

Jan-25

60.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230543

Jan-25

61.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230561

Jan-25

62.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230619

Feb-25

63.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230624

Feb -25

64.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230879

Mar -25

65.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230890

Mar -25

66.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230918

Mar -25

67.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230984

Mar -25

68.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17230996

Mar-25

69.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231002

Mar-25

70.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231081

Mar-25

71.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231102

Apr-25

72.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231135

Apr-25

73.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231329

Apr-25

74.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231369

May-25

75.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231513

May-25

76.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231516

Jun-25

77.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231713

Jun-25

78.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231909

Jul -25

79.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231903

Jul -25

80.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17231943

Aug-25

81.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17232166

Sep -25

82.

68462-357-01

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 100 count

17232179

Sep -25

83.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230186

Dec-24

84.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230192

Dec-24

85.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230213

Dec-24

86.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230278

Dec-24

87.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230399

Dec-24

88.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230406

Jan-25

89.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230412

Jan-25

90.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230427

Jan-25

91.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230444

Jan-25

92.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230453

Jan-25

93.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230495

Jan-25

94.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230574

Feb-25

95.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230585

Feb-25

96.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230608

Feb-25

97.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230629

Feb – 25

98.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230883

Mar -25

99.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17230921

Mar -25

100.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231087

Apr- 25

101.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231339

Apr-25

102.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231360

May-25

103.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231711

Jun-25

104.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231745

Jun-25

105.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231819

Jul-25

106.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231820

Jul-25

107.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231936

Jul-25

108.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231957

Jul-25

109.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17231998

Aug-25

110.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17232012

Aug-25

111.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17232110

Sep- 25

112.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17232114

Aug-25

113.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17232119

Sep- 25

114.

68462-357-05

Potassium Chloride Extended-Release Capsules USP

(750 mg) 10 mEQ K – 500 count

17232343

Sep- 25

Glenmark is notifying its wholesale and distributor customers by written letters and is arranging for return of all recalled batches. Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter. Wholesalers and distributors should conduct a sub-recall to retail or pharmacy customers.

Consumers that have Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should call Inmar Rx Solutions at 1-877-883-9273, Monday – Friday, 9:00 am – 5:00 pm EST for return instructions and for further information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact: Glenmark Drug Safety
Phone Number: 1-888-721-7115

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SOURCE Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ