Cipla USA, Inc.: Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc.
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Cipla USA, Inc.
- Product
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
- Reason / hazard
- Failed stability specifications: Out of specification for hardness test
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2025-10-24
- Code info
- Lot# NB240314, exp 12/31/2025
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warren
- State
- NJ
- Country
- United States
- Event id
- 97855
Free daily digest + "My products" watchlist