June 2024 FDA Recall Sevelamer Carbonate For Oral Suspension by Dr. Reddy's Laboratories, Inc.
D-0625-2024 - Labeling
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on June 26, 2024 for the product Sevelamer Carbonate For Oral Suspension. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0625-2024
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
06-26-2024
08-14-2024
5,136 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : T2305999, Exp. Date 11/2025
