Pravastatin Sodium Tablet
FDA Recall NDC 16714-558
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pravastatin Sodium (NDC 16714-558). A significant event, classified as Class II, was initiated on Mar 13, 2025 by Northstar Rxllc. 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, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
Batch or Lot Expiration Information
Lot# 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26
Affected Packages Involved in this Recall
16714-558-01Product
16714-558-02Product
16714-559-01Product
16714-559-02Product
16714-560-01Product
16714-560-02Product
16714-570-01Product
16714-570-02Product
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, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
Batch or Lot Expiration Information
Lot# 17230810, exp. date Mar-26
Affected Packages Involved in this Recall
16714-558-01Product
16714-558-02Product
16714-559-01Product
16714-559-02Product
16714-560-01Product
16714-560-02Product
16714-570-01Product
16714-570-02Product
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.
