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Recall Observatory FDA recall evidence

Food product

Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4

F-0916-2013

November 13, 2012

Class II

Product summary

Firm
Cardinal Health
Event
Event 63955
Status
Terminated
Classification
Class II
Quantity
1,140 caplets
Official record key
food-enforcement:F-0916-2013

Official wording

Reason: The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.

Code information: White, oblong caplet, imprinted RP143; Batch# M675030, Lot # 10627AA, Exp Date 11/2012; Batch# M679370, Lot # 10627BA, Exp Date 12/2012; Batch# M675020, Lot # 10627A, Exp Date 11/2012; Batch# M679360, Lot # 10627B, Exp Date 12/2012; Batch# M707960, Lot # 10627C, Exp Date 3/2013; Batch# M712800, Lot # 11469A, Exp Date 3/2013; Batch# M740490, Lot # 11464B, Exp Date 6/2013 & Batch# M743510, Lot # 13973A, Exp Date 7/2013.

Distribution pattern: Product was shipped to the following states: NJ & NY

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling bears an incorrect
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    incorrect strength