Mylan Recalls Tarina Fe 1/20 Tablets Due to Chemical Contamination
Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.
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 indicates the use of, or exposure to, the product is not likely to cause adverse health consequences. The hazard is a chemical contamination from paint thinner vapors, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 43,848 cartons of Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets). The affected product is identified by Lot # 6843F002D with an expiration date of 02/18. The product was distributed nationwide in the USA.
The recall was initiated because out-of-specification results for impurities were found in the product. The contamination was determined to be the result of vapors associated with paint thinner used in the repair of the manufacturing room.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The product is prescription-only and was manufactured for Afaxys, Inc.
The recalled product
- Product
- Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured…
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 43,848
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 #: 6843F002D
- 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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