Drug product
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
D-0625-2024
Product summary
- Event
- Event 94884
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 5,136 cartons
- Official record key
drug-enforcement:D-0625-2024
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Code information: Lot #: T2305999, Exp. Date 11/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing