Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bo...
FDA Drug Recall #D-0775-2016 — Class III — January 15, 2016
Recall Summary
| Recall Number | D-0775-2016 |
| Classification | Class III — Low risk |
| Date Initiated | January 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Virtus Pharmaceuticals, Llc |
| Location | Tampa, FL |
| Product Type | Drugs |
| Quantity | 1,139 bottles total |
Product Description
Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
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).
Distribution Pattern
MI
Lot / 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
Other Recalls from Virtus Pharmaceuticals, Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1048-2016 | Class III | VP-CH-PNV Prenatal/Postnatal capsules, prenatal... | May 16, 2016 |
| D-1044-2016 | Class III | Hyoscyamine Sulfate Sublingual Tablets, 0.125 m... | May 13, 2016 |
| D-0801-2016 | Class III | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic... | Dec 17, 2015 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.