Why it was recalled
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Product description
Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
Lot numbers, UPCs & expiration codes
Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017, NDC 76439-264-10, UPC 376439264109
Where it was sold
MI
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-0775-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 15, 2016
- FDA report date
- Mar 23, 2016
- Quantity
- 1,139 bottles total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Virtus Pharmaceuticals, Llc
Original FDA data
Every field from FDA enforcement report D-0775-2016, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 73480
- Address
- 2649 Causeway Center Dr
- Code information
- Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017, NDC 76439-264-10, UPC 376439264109
- Postal code
- 33619-6102
- Report date
- Mar 23, 2016
- Product type
- Drugs
- Recall number
- D-0775-2016
- Classification
- Class III
- Recalling firm
- Virtus Pharmaceuticals, Llc
- Product quantity
- 1,139 bottles total
- Termination date
- Aug 21, 2018
- Reason for recall
- Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
- Distribution pattern
- MI
- Recall initiation date
- Jan 15, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 14, 2016