Major Poly-Vita Drops 50 mL UPC 00904-5099-50
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
- Major Poly-Vita Drops 50 mL UPC 00904-5099-50
- UPC
- 00904509950
- 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-0630-2018
- Quantity
- Unknown
- Distribution
- MI
- Initiated
- 16 August 2017
- Reported by FDA
- 31 January 2018
- Terminated
- 2 December 2022
- Firm notified by
- 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.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
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.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2018-01-31 | Rugby FER Iron Liquid 50 mL UPC 00536-0710-80 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Leader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL UPC 096295128611 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Rugby Ferrous Sulfate Elixir 473 mL UPC: 00536-0650-85 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Major Certa-Vite Liquid 236 mL UPC 00904-5023-09 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Rugby Calcionate Syrup 16 oz. UPC 00536-2770-85 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Leader Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL UPC 096295128628 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Rugby Polyvitamin Liquid 1 2/3 fl. oz. (50 mL) UPC 00536-8450-80 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Major Tri-Vita Drops 50 mL UPC 00904-6274-50 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Major Ferrous Drop Iron Supplement 50 mL UPC 00904-6060-50 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
| 2018-01-31 | Major D-Vita Drops 50 mL UPC 00904-6273-50 | Pharmatech LLC | Presence of yeast and potential contamination with B. cepacia. | Class II |
All 42 records for Pharmatech LLC
All 2018 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.