Skip to content
Recall Observatory FDA recall evidence

Drug product

Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284

D-0675-2017

January 05, 2017

Class III

Product summary

Firm
InnovaGel
Event
Event 76933
Status
Terminated
Classification
Class III
Quantity
9,992,768 softgels
Official record key
drug-enforcement:D-0675-2017

Official wording

Reason: Subpotent

Code information: Batch #: 1508803,1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, 1606804, Exp. 08/03/2018.

Distribution pattern: NY only

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent