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Recall Observatory FDA recall evidence

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

June 26, 2024

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing