FDAClass IIIAugust 14, 2024

Sevelamer Carbonate for Oral Suspension recall: Labeling Error

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

Why was Sevelamer Carbonate for Oral Suspension recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: T2305999, Exp. Date 11/2025

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
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
5,136 cartons
Distribution
Nationwide within the United States
Recall date
August 14, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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