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Recall Observatory FDA recall evidence

Drug product

Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

D-0775-2016

January 15, 2016

Class III

Product summary

Firm
Virtus Pharmaceuticals, Llc
Event
Event 73480
Status
Terminated
Classification
Class III
Quantity
1,139 bottles total
Official record key
drug-enforcement:D-0775-2016

Official wording

Reason: 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).

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

Distribution pattern: MI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).