Drug 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.
D-0218-2026
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 97855
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0218-2026
Official wording
Reason: Failed stability specifications: Out of specification for hardness test
Code information: Lot# NB240314, exp 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification