Rugby Calcionate Syrup 16 oz. UPC 00536-2770-85

Pharmatech LLC recalled this product and the FDA reported the enforcement action on 31 January 2018 as Class II. The recall was initiated by the firm. Presence of yeast and potential contamination with B. 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

Rugby Calcionate Syrup 16 oz. UPC 00536-2770-85

UPC

00536277085

Reason for recall

Presence of yeast and potential contamination with B. cepacia.

Recalling firm

Pharmatech LLC

Firm location

Davie, Florida, United States

Classification

Class II

Status

Terminated

Recall number

F-0624-2018

Quantity

Unknown

Distribution

MI

Initiated

16 August 2017

Reported by FDA

31 January 2018

Terminated

2 December 2022

Firm notified by

E-Mail

Product codes

All lots remaining within expiry

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 17 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 17 separate recalls, which almost every published figure does, overstates it by a factor of 17. 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 17 of them.
• The recall ran for 5.3 years, from 16 August 2017 to termination on 2 December 2022. 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 1 state, and the FDA published the enforcement report 6 months after the firm began the recall.
• Recalls of a sauce, dip or condiment run a median of 6 months, so this one was longer than usual for its category. Sauces and dips sit at the intersection of the acidified foods rule and the allergen rule: an equilibrium pH above 4.6 turns a shelf-stable product into a botulism risk, and the ingredient list is long enough that an allergen is easy to lose.

What this recall was for

Filed under sauces, dips and condiments. A product can sit in more than one.

Other sauces, dips and condiments recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. 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 2018 recalls · All FDA food recall data