FDA recall D-246-2013

Product

Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

Reason for recall

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-12

Report date

2013-04-17

Termination date

2014-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-246-2013