FDA recall D-1434-2012

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05

Reason for recall

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-04-09
Report date: 2012-08-08
Termination date: 2013-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1434-2012