The Recall Desk
ModerateFDA (Drugs)·D-0861-2017·Announced 2017-05-31

Mylan Recalls Norethindrone Acetate and Ethinyl Estradiol Tablets Due to Contamination

Mylan Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to chemical contamination from paint thinner vapors during facility repairs.

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 presence of chemical contamination from paint thinner vapors, a score of 2 (Moderate) is appropriate as it is not merely a cosmetic or documentation issue.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg. The affected product is packaged in 3 pouches, each containing one blister pack of 21 tablets (NDC 0378-7280-53). The recall involves 8,605 cartons distributed nationwide in the USA.

The recall was initiated because out-of-specification results for impurities were found in the product. The contamination was caused by vapors associated with paint thinner used during the repair of the manufacturing room. The specific lot number is 6327A006, with an expiration date of 02/18.

Consumers should check their medication for the specific NDC and lot number listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL)
Brand
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
8,605

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 (2)

  • Lot #: 6327A006
  • Exp 02/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mylan Pharmaceuticals 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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