Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalled over labeling errors

Recall date

September 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Xiromed LLC recalls Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 table…

Recall number

D-0016-2019

FDA classification

Class III

Brand / firm

Xiromed LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)