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Recall Observatory FDA recall evidence

Food product

Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.

F-0259-2017

August 08, 2016

Class II

Product summary

Firm
Pharmatech LLC
Event
Event 75272
Status
Terminated
Classification
Class II
Quantity
75,972 bottles
Official record key
food-enforcement:F-0259-2017

Official wording

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

Code information: UPC No. 005360650858; Lot No. 22461511 & 22461512, Exp. Date 10/2017; Lot No. 22461513 & 22461514, Exp. Date 11/2017; Lot No. 22461515 & 22461516, Exp. Date 12/2017; Lot No. 22461601 & 22461602, Exp. Date 02/2018; Lot No. 22461603 & 22461604, Exp. Date 04/2018; Lot No. 22461605 & 22461606, 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