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.
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 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.
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