Pravastatin Sodium Tablet
FDA Recall NDC 68462-196
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Pravastatin Sodium (NDC 68462-196). A significant event, classified as Class II, was initiated on Mar 13, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
Batch or Lot Expiration Information
Lot# 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26
Affected Packages Involved in this Recall
68462-195-90Product
68462-195-05Product
68462-196-90Product
68462-196-05Product
68462-197-90Product
68462-197-05Product
68462-198-90Product
68462-198-05Product
Class II Ongoing
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
Batch or Lot Expiration Information
Lot# 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26
Affected Packages Involved in this Recall
68462-195-90Product
68462-195-05Product
68462-196-90Product
68462-196-05Product
68462-197-90Product
68462-197-05Product
68462-198-90Product
68462-198-05Product
Class II Ongoing
Failed Dissolution Specifications: results below specifications
Jun 28, 2024
Jul 24, 2024
a) 145,800 bottles; b) 1,368 bottles
Recall Profile & Regulatory Data
Event ID
94899
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Batch or Lot Expiration Information
Lot# : a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024
Affected Packages Involved in this Recall
68462-195-90Product
68462-195-05Product
68462-196-90Product
68462-196-05Product
68462-197-90Product
68462-197-05Product
68462-198-90Product
68462-198-05Product
Class II Terminated
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Mar 25, 2019
Apr 17, 2019
2076 500-count Bottles
Recall Profile & Regulatory Data
Event ID
82461
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 14, 2020
Product Description
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Batch or Lot Expiration Information
Lot# Lot 17181491 Exp. Aug. 2021
Affected Packages Involved in this Recall
68462-195-90Product
68462-195-05Product
68462-196-90Product
68462-196-05Product
68462-197-90Product
68462-197-05Product
68462-198-90Product
68462-198-05Product
Class III Terminated
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Apr 05, 2013
May 22, 2013
246,528 bottles
Recall Profile & Regulatory Data
Event ID
64995
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Generics Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 09, 2014
Product Description
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# 02121059 Exp 03/15
Lot# 02121484 Exp 04/15
Lot# 02121530 Exp 04/15
Lot# 02121665 Exp 05/15
Lot# 02121669 Exp 05/15
Lot# 02121689 Exp 05/15
Lot# 02121705 Exp 05/15
Lot# 02123434 Exp 10/15
Lot# 02123446 Exp 10/15
Lot# 02123633 Exp 11/15
Lot# 02123677 Exp 11/15
Lot# 02123685 Exp 11/15
Lot# 02123695 Exp 11/15
Lot# 02123823 Exp 11/15
Lot# 02123833 Exp 11/15
Lot# 02123836 Exp 11/15
Lot# 02123853 Exp 11/15
Lot# 02123859 Exp 11/15
Lot# 02130021 Exp 12/15
Lot# 02130059 Exp 12/15
Lot# 02130079 Exp 12/15
Affected Packages Involved in this Recall
68462-195-90Product
68462-195-05Product
68462-196-90Product
68462-196-05Product
68462-197-90Product
68462-197-05Product
68462-198-90Product
68462-198-05Product
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.
