Virt-Nate Prenatal Supplement Recalled for Incorrect Tablet Imprinting
Virtus Pharmaceuticals is recalling Virt-Nate Prenatal/Postnatal supplements because some bottles contain tablets with the wrong identification code.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a cosmetic labeling error (incorrect tablet imprint) rather than a contamination or dosage error.
Plain-English summary
Virtus Pharmaceuticals, LLC is recalling 1,139 bottles of Virt-Nate Prenatal/Postnatal, a prescription folate-containing dietary supplement. The recall is due to tablets being debossed with an incorrect identification code. Specifically, some bottles may contain tablets marked with V259, which is the code for PreTab, instead of the correct code V264 for Virt-Nate.
The affected products are 100-count bottles distributed in Michigan. The recall includes two lot codes: M143810A (exp 7/2017, NDC 69543-264-10, UPC 369543264105) and M143810 (exp 7/2017, NDC 76439-264-10, UPC 376439264109).
Consumers with these products should check their bottles for the specific lot codes and expiration dates listed above. If the product matches the description, they should stop using it and contact their healthcare provider or the manufacturer for instructions on disposal or replacement.
The recalled product
- Product
- Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
- Manufacturer
- Virtus Pharmaceuticals, Llc
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 1,139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot code M143810A
- exp 7/2017
- NDC 69543-264-10
- UPC 369543264105
- and Lot code M143810
- NDC 76439-264-10
- UPC 376439264109
Distribution
Distributed in 1 state:
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