Sevelamer Carbonate For Oral Suspension Powder, For Suspension
FDA Recall NDC 43598-478
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sevelamer Carbonate For Oral Suspension (NDC 43598-478). A significant event, classified as Class III, was initiated on Jun 26, 2024 by Dr. Reddys Laboratories Inc. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Jun 26, 2024
Aug 14, 2024
5,136 cartons
Recall Profile & Regulatory Data
Event ID
94884
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Affected Packages Involved in this Recall
43598-478-01Product
43598-478-90Product
43598-479-01Product
43598-479-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
