Recalls / Class II
Class IID-0339-2025
Product
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30
- Brand name
- Rosuvastatin Calcium
- Generic name
- Rosuvastatin Calcium
- Active ingredient
- Rosuvastatin Calcium
- Route
- Oral
- NDCs
- 68462-261, 68462-262, 68462-263, 68462-264
- FDA application
- ANDA079172
- Affected lot / code info
- Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-26
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- Glenmark Pharmaceutials Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.