Junel(TM) Fe 1.5/30 recall: Impurity Out of Spec
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr…
Why was Junel(TM) Fe 1.5/30 recalled?
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
- Product
- Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr…
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Quantity
- 47,200 blister packs
- Distribution
- Nationwide distribution. No foreign or government accounts.
- Recall date
- July 17, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)