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., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
- 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# NB240315, exp 12/31/2025
- Product quantity
- 1180 boxes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warren
- State
- NJ
- Country
- United States
- Event id
- 97855
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