The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0241-2017·Announced 2017-01-04

VirtPrex Prenatal Tablets Recalled Due to API Manufacturer Import Alert

Virtus Pharmaceuticals is recalling VirtPrex Prenatal/Postnatal Tablets because the active ingredient manufacturer is on an FDA Import Alert.

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 by definition is unlikely to cause adverse health consequences. The hazard is related to manufacturing deviations rather than a direct, immediate physical danger like fire or choking.

Plain-English summary

Virtus Pharmaceuticals is recalling VirtPrex Prenatal/Postnatal Tablets, a prescription supplement containing folic acid and DHA. The recall involves 124,250 bottles distributed nationwide. The product is packaged in 30-count bottles and is made in Canada.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the manufacturer of the Active Pharmaceutical Ingredient (API) is currently on an FDA Import Alert. This classification indicates that the agency has identified issues with the manufacturing process or quality control of the raw materials used in the product.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected lots include specific expiration dates ranging from May 2017 to November 2017. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
Manufacturer
VIRTUS PHARMACEUTICALS OPCO II L
Category
Drug — Prescription Supplement
Hazard
Affected units
124,250

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 (5)

  • Lots #: 21506124 Exp. Date 5/30/2017
  • 21511151 Exp. date 10/30/2017
  • 21511151A Exp. Data 10/30/2017
  • 21512163 Exp. date 11/30/2017
  • 21512164 Exp. date 11/30/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by VIRTUS PHARMACEUTICALS OPCO II L under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · VIRTUS PHARMACEUTICALS OPCO II L

See all →

Same hazard · cGMP deviation

See all →

Similar recalls