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.
Reported: April 16, 2025 Initiated: March 13, 2025 #D-0325-2025
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.
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 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.. 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-0325-2025.
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