Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Reported: July 17, 2013 Initiated: March 15, 2013 #D-689-2013
Product Description
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
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
- 154,536 cartons
- Distribution
- Nationwide and Puerto Rico
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 154,536 cartons.
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-689-2013.
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