The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-689-2013·Announced 2013-07-17

Teva Recalls Errin Norethindrone Tablets Due to Impurity Detection

Teva Pharmaceuticals is recalling Errin (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 agency classified this as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a chemical impurity detected during testing, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 154,536 cartons of Errin (norethindrone tablets, USP), 0.35 mg. The product is a prescription-only medication used for a 28-day regimen. The recall covers specific lots distributed nationwide and in Puerto Rico.

The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing. This indicates a failure to meet impurity and degradation specifications. The affected lots have expiration dates ranging from July 2014 to June 2015.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for disposal or replacement. No specific instructions for patient management are provided in the source text beyond the recall action.

The recalled product

Product
Errin (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 0555-0344-58
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
154,536

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 (20)

  • Lot #s: 33801773A
  • Exp 7/14
  • 33801774A
  • Exp 8/14
  • 33801775A
  • 33801776A
  • Exp 9/14
  • 33802427A
  • 33802428A
  • 33802429A
  • 33802430A
  • Exp 12/14
  • 33802925A
  • 33802926A
  • Exp 3/15
  • 33803383A
  • 33803384A
  • 33803385A
  • 33803387A
  • 33803685A

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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