Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Reported: July 17, 2013 Initiated: March 15, 2013 #D-683-2013
Product Description
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 54,412 blister packs
- Distribution
- Nationwide distribution. No foreign or government accounts.
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 54,412 blister packs.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2013. Severity: Low. Recall number: D-683-2013.
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