Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Lot numbers, UPCs & expiration codes
Lot H2200493; Exp 6/30/2025
Where it was sold
US Nationwide.
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-0504-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 1, 2024
- FDA report date
- May 29, 2024
- Quantity
- 1,176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0504-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94535
- Address
- 107 College Rd E
- Code information
- Lot H2200493; Exp 6/30/2025
- Postal code
- 08540-6623
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0504-2024
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1,176 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 1, 2024
- Center classification date
- May 21, 2024