FDAFDA · Food and drugs·Recall number D-0341-2025
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.
Published April 16, 2025 · Recall initiated: March 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- U.S. Nationwide
- UPC
- 0368462195901
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.