The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-682-2013·Announced 2013-07-17

Teva Recalls Junel Oral Contraceptive Due to Impurity Detection

Teva Pharmaceuticals is recalling Junel oral contraceptives 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a chemical impurity detected during testing, with no reported illnesses or injuries.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 47,200 blister packs of Junel (norethindrone acetate and ethinyl estradiol) oral contraceptives. The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing, which failed the product's impurity/degradation specifications.

The affected product is Junel Fe 1.5/30, a 28-day regimen prescription drug manufactured by Barr Laboratories in Pomona, NY. The specific NDC number is 0555-9028-58. The recall covers lot numbers 33802123A (exp 4/2013), 33802202A (exp 5/2013), 33802203A (exp 5/2013), and 33802204A (exp 5/2013).

The product was distributed nationwide, with no foreign or government accounts involved. Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement, as per standard recall procedures.

The recalled product

Product
JUNEL (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL)
Brand
JUNEL
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
47,200

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 0555-9028-58
  • Lot numbers 33802123A
  • exp 4/2013
  • 33802202A
  • exp 5/2013
  • 33802203A
  • and 33802204A
  • exp 5/2013.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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