Virtus Pharmaceuticals Recalls Prenatal Supplement Due to Leaking Capsules
Virtus Pharmaceuticals is recalling prenatal/postnatal folic acid supplements because the capsules may leak. The recall covers 688 bottles distributed nationwide.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a packaging defect (leaking capsules) rather than a toxicological or biological risk.
Plain-English summary
Virtus Pharmaceuticals, LLC is recalling VP-CH-PNV Prenatal/Postnatal Prescription Folic Acid-Containing Dietary Supplement, 30-count softgel bottles. The recall involves 688 bottles (20,640 softgel capsules) with Lot #21506132 and an expiration date of 05/17. The product was distributed nationwide.
The recall was initiated due to a defective delivery system, as the product may contain leaking capsules. This is classified as an FDA Class III recall, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
- Manufacturer
- Virtus Pharmaceuticals, Llc
- Category
- Drug — Dietary Supplement
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 (2)
- Lot #21506132
- Exp. 05/17
Distribution
Distributed nationwide across the United States.
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