Potassium Chloride Tablet, Extended Release
FDA Recall NDC 64380-861
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Potassium Chloride (NDC 64380-861). A significant event, classified as Class II, was initiated on Sep 27, 2021 by Strides Pharma Science Limited. The reported reason for this action was: "Failed Dissolution Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications
Sep 27, 2021
Oct 20, 2021
1813 bottles
Recall Profile & Regulatory Data
Event ID
88759
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 26, 2022
Product Description
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Batch or Lot Expiration Information
Lot# Lot 7240840A, exp. 12/31/2021
Affected Packages Involved in this Recall
64380-860-06Product
64380-860-07Product
64380-860-08Product
64380-861-06Product
64380-861-07Product
64380-861-08Product
Class II Terminated
Failed Dissolution Specifications
Aug 24, 2020
Oct 07, 2020
11,280 bottles
Recall Profile & Regulatory Data
Event ID
86283
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Jan 11, 2022
Product Description
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06
Batch or Lot Expiration Information
Lot# 7240675A; Exp. 12/31/2021
Affected Packages Involved in this Recall
64380-860-06Product
64380-860-07Product
64380-860-08Product
64380-861-06Product
64380-861-07Product
64380-861-08Product
Class III Terminated
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Feb 17, 2020
Mar 25, 2020
2576 bottles
Recall Profile & Regulatory Data
Event ID
84968
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Science Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Feb 16, 2021
Product Description
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
Batch or Lot Expiration Information
Lot# : 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Affected Packages Involved in this Recall
64380-860-06Product
64380-860-07Product
64380-860-08Product
64380-861-06Product
64380-861-07Product
64380-861-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
