Drug 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.
Lots and codes
Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Recall details
- Recalling firm
- Xiromed LLC, Florham Park, NJ
- Quantity
- 40064 3x28 units
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 18, 2018
- Terminated
- March 26, 2019
Related products
- Altavera – drug information
- NDC 70700-116 Altavera · · Xiromed, LLC.