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Recall Observatory FDA recall evidence

Food product

Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.

F-0266-2017

August 08, 2016

Class II

Product summary

Firm
Pharmatech LLC
Event
Event 75272
Status
Terminated
Classification
Class II
Quantity
42,984 bottles
Official record key
food-enforcement:F-0266-2017

Official wording

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

Code information: NDC No. 0904-5099-50; Lot No. 20701509 & 20701511, Exp. Date 09/2017; Lot No. 20701513, Exp. Date 12/2017; Lot No. 20701601, Exp. Date 02/2018; Lot No. 20701602 & 20701603, Exp. Date 04/2018; Lot No. 20701606, Exp. Date 06/2016.

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination with Burkholderia cepacia