POTASSIUM CHLORIDE

Generic: POTASSIUM CHLORIDE

Tris Pharma IncManufacturer

ORALRoute

POTASSIUM CHLORIDEActive Substance

2022-01-26Original Approval

POTASSIUM CHLORIDE is FDA application ANDA214076, sponsored by TRIS PHARMA INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2024-07-02

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100

Defective container: potential for non-sealed pouches which can lead to product leakage.

Class I2014-07-11

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corp

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Class II2024-03-06

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,

Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifi

Class II2025-01-30

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),

Failed Dissolution Specifications.

Class I2024-06-25

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-co

Failed Dissolution Specifications

Class II2014-09-08

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container b

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection

Class II2024-05-30

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma

CGMP Deviations

Class I2025-02-13

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may co

Class I2024-05-30

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma

Failed Dissolution Specifications

Class III2020-02-17

Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Sh

Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride

POTASSIUM CHLORIDE

Recalls

Top Reported Reactions