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

FDA recall notice · announced October 17, 2018 · Xiromed

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Quantity: 40064 3x28 units
Status: Terminated
Products in this recall event:
- 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., Florh (D-0016-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.