FDA-Drug2013-07-17Class III

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

Teva Pharmaceuticals USA, Inc.
Hazard

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Sold states
Nationwide distribution. No foreign or government accounts.
Affected count
148,785 blister packs
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-681-2013

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief