The Recall Desk
ModerateFDA (Drugs)·D-497-2013·Announced 2013-06-05

Teva Recalls Camrese Oral Contraceptives Due to Impurity Detection

Teva Pharmaceuticals is recalling Camrese oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

What this means for you

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 recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. Given the detection of a specific impurity in a prescription drug, a score of 2 (Moderate) is appropriate as it is not merely cosmetic but involves a chemical specification failure, though it is unlikely to cause adverse health consequences per the Class III definition.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 120,049 blister packs of Camrese (Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol) tablets. The affected products are distributed nationwide and include specific lot numbers with expiration dates ranging from March 2013 to November 2013.

The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing. This failure to meet impurity/degradation specifications prompted the action.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative contraception. The recall is classified as Class III by the FDA.

The recalled product

Product
CAMRESE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL)
Brand
CAMRESE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
120,049

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 (8)

  • NDC 0555-3134-82 and 0093-3134-91 -- lot numbers 33802566A
  • exp 3/2013
  • 33802967A
  • exp 8/2013
  • 33803529A
  • exp 10/2013
  • and 33803609A
  • exp 11/2013.

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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Same manufacturer · Teva Pharmaceuticals USA, Inc.

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Same hazard · impurity detection

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