Recalls / Class III
Class IIID-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)
- Brand name
- Altavera
- Generic name
- Levonorgestrel And Ethinyl Estradiol
- NDC
- 70700-116
- FDA application
- ANDA079102
- Affected lot / code info
- Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Why it was recalled
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Recalling firm
- Firm
- Xiromed LLC
- Manufacturer
- Xiromed, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 180 Florham Park, Suite 101, Florham Park, New Jersey 07932
Distribution
- Quantity
- 40064 3x28 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-09-18
- FDA classified
- 2018-10-11
- Posted by FDA
- 2018-10-17
- Terminated
- 2019-03-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0016-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.