FDA recall D-0506-2017

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

Product

Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81

Reason for recall

Failed dissolution specifications - low dissolution results at S3 stage.

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2017-02-15
Report date: 2017-03-08
Termination date: 2018-12-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2017