FDAHealthMarch 13, 2025
Glenmark Pharmaceuticals Inc., USA — 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 Pharmaceutic
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2025
U.S. Nationwide
What's affected?
- Product
- 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.
- Brand
- PRAVASTATIN SODIUM
- UPC
- 0368462195901
- Lot code
- 17230810
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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