FDA recall D-0649-2017

Dr. Reddy's Laboratories, Inc. · Class III · 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

Reason for recall

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

Distribution

U.S. nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-06
Report date: 2017-04-12
Termination date: 2017-12-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2017