Why it was recalled
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Product description
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Lot numbers, UPCs & expiration codes
Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Where it was sold
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-1063-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 3, 2016
- FDA report date
- Jul 13, 2016
- Quantity
- 9,330 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1063-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74325
- Address
- 107 College Rd E
- Code information
- Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
- Postal code
- 08540-6623
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1063-2016
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 9,330 bottles
- Termination date
- Apr 7, 2017
- Reason for recall
- Failed impurities/degradation: out of specification result for impurity secorapamycin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 5, 2016