FDASeptember 18, 2018drug
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)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
What to do
FDA enforcement status: Terminated
Brands named
xiromed
Recall history
No related federal recalls on record for this brand yet.
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