FDAFDA · Food and drugs·Recall number D-246-2013
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.
Published April 17, 2013 · Recall initiated: March 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- JOLESSA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Nationwide
- Lot
- Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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