Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun
Summary
The FDA issued a Class II for Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, R by Strides Pharma Inc.. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0006-2022
Action Date
2021-10-20
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot 7240840A, exp. 12/31/2021
Quantity Affected: 1813 bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-27
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Strides Pharma Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Strides Pharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Strides Pharma Inc. have FDA actions?
Strides Pharma Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0006-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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