The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-690-2013·Announced 2013-07-17

Teva Recalls Camila Norethindrone Tablets Due to Impurity Detection

Teva Pharmaceuticals is recalling Camila (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

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 the product is unlikely to cause adverse health consequences. The hazard is a detected impurity without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 59,240 cartons of Camila (norethindrone tablets, USP), 0.35 mg. The product is a prescription-only oral contraceptive containing 28 tablets per blister card, with 6 blister cards per carton. The specific NDC number is 0555-0715-58.

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. The affected lots are 33802107A, 33802108A (Exp 9/13); 33802109A, 33802110A, 33802111A, 33802112A (Exp 10/13); and 33802560A (Exp 1/14).

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with the recall instructions.

The recalled product

Product
Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
59,240

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 (10)

  • Lot #s: 33802107A
  • 33802108A
  • Exp 9/13
  • 33802109A
  • 33802110A
  • 33802111A
  • 33802112A
  • Exp10/13
  • 33802560A
  • Exp 1/14.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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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