Pravastatin Sodium Tablet
FDA Recall NDC 55111-229
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 Pravastatin Sodium (NDC 55111-229). A significant event, classified as Class III, was initiated on Jul 11, 2017 by Dr.reddy's Laboratories Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220."
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 III Terminated
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Jul 11, 2017
Aug 09, 2017
544 bottles
Recall Profile & Regulatory Data
Event ID
77734
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 01, 2019
Product Description
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Batch or Lot Expiration Information
Lot# : a) C700220, Exp 06/18; b) C700220, Exp 06/18
Affected Packages Involved in this Recall
55111-229-30Product
55111-229-90Product
55111-229-01Product
55111-229-05Product
55111-230-30Product
55111-230-90Product
55111-230-01Product
55111-230-05Product
55111-231-30Product
55111-231-90Product
55111-231-01Product
55111-231-05Product
55111-274-30Product
55111-274-90Product
55111-274-01Product
55111-274-05Product
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.
