FDA recall D-245-2013

Product

Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.

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-245-2013