The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-496-2013·Announced 2013-06-05

Teva Recalls Seasonale Tablets Due to Impurity Detection

Teva Pharmaceuticals is recalling Seasonale tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates a remote possibility of adverse health consequences. The hazard involves an impurity detected during testing, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 17,108 blister packs of Seasonale (Levonorgestrel/Ethinyl Estradiol) tablets. The affected product is an extended-cycle oral contraceptive containing 91 tablets per dispenser, identified by NDC 51285-058-66. The recall covers lot numbers 33802330A and 33802464A, both with an expiration date of 6/2013.

The recall was initiated because impurity testing identified N-Butyl-Benzene Sulfonamide (NBBS) in the product. This failure of the impurity/degradation specification prompted the company to remove the affected units from distribution.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
17,108

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 (4)

  • NDC 51285-058-66 -- lot numbers 33802330A
  • exp 6/2013
  • and 33802464A
  • exp 6/2013.

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.

See all 2 products in this recall →

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