Recalls / Class III
Class IIID-0625-2024
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
- Brand name
- Sevelamer Carbonate For Oral Suspension
- Generic name
- Sevelamer Carbonate For Oral Suspension
- Active ingredient
- Sevelamer Carbonate
- Route
- Oral
- NDCs
- 43598-478, 43598-479
- FDA application
- ANDA210464
- Affected lot / code info
- Lot #: T2305999, Exp. Date 11/2025
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 5,136 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-06-26
- FDA classified
- 2024-08-02
- Posted by FDA
- 2024-08-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0625-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.