FDA recall D-1436-2012

Product

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

Reason for recall

Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2012-06-05

Report date

2012-08-08

Termination date

2013-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1436-2012