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Recall Observatory FDA recall evidence

Food product

CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.

F-0265-2017

August 08, 2016

Class II

Product summary

Firm
Pharmatech LLC
Event
Event 75272
Status
Terminated
Classification
Class II
Quantity
110,136 bottles
Official record key
food-enforcement:F-0265-2017

Official wording

Reason: Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.

Code information: NDC No. 0904-5023-09; Lot No. 20471602, Exp. Date 01/2018; Lot No. 20471603 & 20471604, Exp. Date 02/2018; Lot No. 20471605 & 20171606, Exp. Date 03/2018; Lot No. 20471607, Exp. Date 04/2018; Lot No. 20471609, 20471611& 20471612, Exp. Date 05/2018.

Distribution pattern: FL, MI, MS, and OH.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination with Burkholderia cepacia