D-0016-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 17, 2018
- Initiation Date
- September 18, 2018
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40064 3x28 units
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020