Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.

Pharmatech LLC recalled this product and the FDA reported the enforcement action on 2 November 2016 as Class II. The recall was initiated by the firm. Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.

Reason for recall

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

Recalling firm

Pharmatech LLC

Firm location

Davie, Florida, United States

Classification

Class II

Status

Terminated

Recall number

F-0262-2017

Quantity

188,640 bottles

Distribution

FL, MI, MS, and OH.

Initiated

8 August 2016

Reported by FDA

2 November 2016

Terminated

23 September 2024

Firm notified by

Letter

Product codes

UPC No. 005368450801; Lot No. 20701511, Exp. Date 09/2018; Lot No. 20701514, Exp. Date 12/2017; Lot No. 20701605, Exp. Date 05/2018; Lot No. 20701606, Exp. Date 06/2018.

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This is one of 23 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 23 separate recalls, which almost every published figure does, overstates it by a factor of 23. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 23 of them.
• The recall ran for 8.1 years, from 8 August 2016 to termination on 23 September 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The distribution pattern names 4 states, and the FDA published the enforcement report 3 months after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was longer than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Named in the distribution pattern: Florida, Michigan, Mississippi, Ohio. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Other records from Pharmatech LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 41 other records name this firm.

All 42 records for Pharmatech LLC

All 2016 recalls · All FDA food recall data