FDA recall D-0098-2017

Product

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

Reason for recall

Failed Dissolution Specifications

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2016-08-29

Report date

2016-10-19

Termination date

2019-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0098-2017