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
Reported: April 16, 2025 Initiated: March 13, 2025 #D-0350-2025
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
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- N/A
- Distribution
- U.S. Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0350-2025.
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