Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's La
Summary
The FDA issued a Class II for Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, by Dr. Reddy's Laboratories, Inc.. Reason: Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and.
Details
Source
Drug Recall
External ID
D-0085-2022
Action Date
2021-11-10
Status
Terminated
Category
drug
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
Lot/Code Info: L100208, exp 01/2023
Quantity Affected: 696 bottles
Reason for Recall
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-05
Company
Princeton, 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 79 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 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 (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0085-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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