FDA Recall D-0625-2024
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class III Ongoing 687 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Recall record
- Recall number
D-0625-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-06-26
- Classified by FDA Center
- 2024-08-02
- FDA published
- 2024-08-14
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- SEVELAMER CARBONATE FOR ORAL SUSPENSION
- Generic name(s)
- SEVELAMER CARBONATE FOR ORAL SUSPENSION
- Manufacturer(s)
- Dr. Reddys Laboratories Inc
- NDC(s)
43598-478, 43598-479- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.