Drug product

RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60

D-0649-2017

March 06, 2017

Class III

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 76699
Status: Terminated
Classification: Class III
Quantity: 1,728 bottles
Official record key: drug-enforcement:D-0649-2017

Official wording

Reason: Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

Code information: Lot #C607323, Exp 10/18

Distribution pattern: U.S. nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.