PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 7, 2020 Initiated: August 24, 2020 #D-0001-2021

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

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Strides Inc.
Units Affected
11,280 bottles
Distribution
nationwide
Location
Lambertville, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Strides Inc.. Units affected: 11,280 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-0001-2021.