Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Scie
Summary
The FDA issued a Class II for Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx by Strides Pharma Inc.. Reason: Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet..
Details
Source
Drug Recall
External ID
D-0895-2023
Action Date
2023-07-12
Status
Terminated
Category
drug
Product Description
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08
Lot/Code Info: Lot#: 7901903A, exp. date 04/2024
Quantity Affected: 2,700 HDPE Bottles
Reason for Recall
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-26
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 32 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-0895-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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