Pravastatin Sodium Tablet
FDA Recall NDC 68180-487
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 68180-487). A significant event, classified as Class II, was initiated on Nov 17, 2017 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle."
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
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Nov 17, 2017
Nov 29, 2017
N/A
Recall Profile & Regulatory Data
Event ID
78566
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Termination Date
Mar 15, 2019
Product Description
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
Batch or Lot Expiration Information
Lot# G702459, Exp 2/20
Affected Packages Involved in this Recall
68180-485-03Product
68180-485-09Product
68180-485-02Product
68180-486-09Product
68180-486-02Product
68180-486-03Product
68180-487-09Product
68180-487-02Product
68180-487-03Product
68180-488-09Product
68180-488-02Product
68180-488-03Product
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.
