Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

FDA recall notice · announced July 13, 2016 · Dr. Reddy's Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

Reason for recall

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Notes

Distribution: Nationwide
Lot/code information: Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Quantity: 9,330 bottles
Status: Terminated
Products in this recall event:
- Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 (D-1063-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.