Drug 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)
D-0016-2019
Product summary
- Firm
- Xiromed LLC
- Event
- Event 81044
- Status
- Terminated
- Classification
- Class III
- Quantity
- 40064 3x28 units
- Official record key
drug-enforcement:D-0016-2019
Official wording
Reason: Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Code information: Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
mislabeling