Teva Recalls Jolessa Contraceptive Tablets Due to Missing Placebo Tablets
Teva Pharmaceuticals is recalling 40,750 dispensers of Jolessa contraceptive tablets because some packages may be missing placebo tablets.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a packaging/sequence defect rather than a contamination or safety hazard.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 40,750 dispensers of Jolessa (levonorgestrel/ethinyl estradiol) tablets. The recall was initiated because some regimen packages may not contain the required placebo tablets.
The affected product is a 91-day regimen, prescription-only contraceptive manufactured by Barr Laboratories, Inc. for Teva Pharmaceuticals. The recall covers specific lots with expiration dates in January, March, and June 2013. The products were distributed nationwide.
Consumers should check their medication packaging to ensure it contains the correct number of tablets. If the placebo tablets are missing, the regimen may not function as intended. Patients should consult their healthcare provider for guidance on alternative contraception or further instructions.
The recalled product
- Product
- JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
- Brand
- JOLESSA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Contraceptive
- Affected units
- 40,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #'s 33801826A
- Exp 1/2013
- 33802144A
- 33802323A
- Exp 3/2013
- 33802519A
- Exp 6/2013
Distribution
Distributed nationwide across the United States.
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