Teva Recalls Portia Tablets Due to Appearance Specification Failures
Teva Pharmaceuticals is recalling Portia (levonorgestrel and ethinyl estradiol) tablets because they failed appearance specifications.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic appearance defect with no reported injuries.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Portia (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg. The recall involves 17,661 blister cards of the 28-count tablets, which are packaged in 6 blister cards per carton. The affected products are identified by Lot # 33801951A and 33802189A, with an expiration date of 03/13.
The recall is being conducted due to an out-of-specification result for the appearance of the tablets. The source text does not specify the nature of the appearance defect or report any illnesses or injuries associated with the product.
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, per standard recall procedures.
The recalled product
- Product
- PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
- Brand
- PORTIA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 17,661
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 (3)
- Lot #: 33801951A
- and 33802189A
- Exp 03/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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