D-0625-2024 Class III Ongoing

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

FDA drug recall D-0625-2024 was initiated by Dr. Reddy's Laboratories, Inc. on June 26, 2024 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets The recall status is ongoing. Affected quantity: 5,136 cartons.

Recall Details

Product Type
Drugs
Report Date
August 14, 2024
Initiation Date
June 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,136 cartons

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

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: T2305999, Exp. Date 11/2025