RecallRadar

FDA Drug recall D-0860-2017

Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablet…

On 2017-05-31 the FDA classified a Class III recall of Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablet… by Mylan Pharmaceuticals, citing chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repai….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0860-2017
ClassificationClass III
Statusterminated
Initiated2017-01-30
Published2017-05-31
Last updated2026-09-13 11:51 UTC
CompanyMylan Pharmaceuticals
DistributionUS

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 for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.

Reason

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Identifiers

code_infoLot #: 6843F002D, Exp 02/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0860-2017%22

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