Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-9
Summary
The FDA issued a Class II for Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 435 by Dr. Reddy's Laboratories, Inc.. Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity.
Details
Source
Drug Recall
External ID
D-0084-2022
Action Date
2021-11-10
Status
Terminated
Category
drug
Product Description
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) 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
Lot/Code Info: a) L100158, exp 12/2022 b) L100159, exp 12/2022
Quantity Affected: a) 11,590 bottles b) 3,585 bottles
Reason for Recall
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
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-0084-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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