Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
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
Lot numbers, UPCs & expiration codes
Lot #: T2305999, Exp. Date 11/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0625-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 26, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 5,136 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0625-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94884
- Address
- 107 College Rd E
- Code information
- Lot #: T2305999, Exp. Date 11/2025
- Postal code
- 08540-6623
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0625-2024
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 5,136 cartons
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 26, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2024