PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: April 17, 2013 Initiated: March 12, 2013 #D-246-2013

Product Description

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.

Details

Units Affected
71,893 dispensers
Distribution
Nationwide
Location
Sellersville, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 71,893 dispensers.
Why was this product recalled?
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2013. Severity: Low. Recall number: D-246-2013.