FDA recall D-1837-2019

Product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Reason for recall

Failed dissolution specifications : failed results at the 3-month stability time point.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2019-07-09

Report date

2019-08-07

Termination date

2021-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1837-2019