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Recall Observatory FDA recall evidence

Drug 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

D-0801-2016

December 17, 2015

Class III

Product summary

Firm
Virtus Pharmaceuticals, Llc
Event
Event 73295
Status
Terminated
Classification
Class III
Quantity
688 bottles ( 20,640 softgel capsules)
Official record key
drug-enforcement:D-0801-2016

Official wording

Reason: Defective Delivery System: Product may contain leaking capsules.

Code information: Lot #21506132; Exp. 05/17

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Delivery System: Product may contain leaking capsules.