Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Reported: November 6, 2024 Initiated: October 9, 2024 #D-0028-2025
Product Description
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Reason for Recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 10584 bottles
- Distribution
- USA Nationwide.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 10584 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2024. Severity: Moderate. Recall number: D-0028-2025.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11