Reported Oct 17, 2018 · Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28…
Xiromed LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xiromed LLC · 180 Florham Park · Florham Park, NJ · 07932
Is this the product you have?
- 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)
- Lot codes and dates
- Lots
LF11838A Expiry May 2020LF12107ALF12106AExpiry June 2020
- Lots
- Amount recalled
- 40064 3x28 units
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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