Amlodipine Besylate And Benazepril Hydrochloride Capsule
FDA Recall NDC 55111-340
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Amlodipine Besylate And Benazepril Hydrochloride (NDC 55111-340). A significant event, classified as Class II, was initiated on Apr 09, 2012 by Dr.reddy's Laboratories Limited. The reported reason for this action was: "Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Apr 09, 2012
Aug 08, 2012
1656 bottles
Recall Profile & Regulatory Data
Event ID
62591
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jan 24, 2013
Product Description
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
Batch or Lot Expiration Information
Lot# C201293 Exp Date 08/2013
Affected Packages Involved in this Recall
55111-338-30Product
55111-338-01Product
55111-338-05Product
55111-339-30Product
55111-339-01Product
55111-339-05Product
55111-340-30Product
55111-340-01Product
55111-340-05Product
55111-341-30Product
55111-341-01Product
55111-341-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
