Why it was recalled
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
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)
Lot numbers, UPCs & expiration codes
Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0016-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 18, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 40064 3x28 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Xiromed LLC
Original FDA data
Every field from FDA enforcement report D-0016-2019, exactly as published.
Show all FDA fields
- City
- Florham Park
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81044
- Address
- 180 Florham Park
- Address (line 2)
- Suite 101
- Code information
- Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
- Postal code
- 07932
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0016-2019
- Classification
- Class III
- Recalling firm
- Xiromed LLC
- Product quantity
- 40064 3x28 units
- Termination date
- Mar 26, 2019
- Reason for recall
- Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2018