FDA recall D-0016-2019

Product

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)

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-09-18

Report date

2018-10-17

Termination date

2019-03-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Florham Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2019