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CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Ingredient containing mold was used in production
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
The firm recieved consumer complaints of premature spoilage of the refrigerated gravy product.
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
This recall involves Model Year 2020-2021 RANGER 1000, RANGER CREW 1000, RANGER XP 1000, and RANGER CREW XP 1000 recreational off-highway vehicles and Model Year 2020 ProXD 2000G, ProXD 2000G H, ProXD 4000G, and ProXD 4000G H off-road utility vehicles. The vehicles were sold in the following colors: black, blue, burgundy, camo, gray, green, orange, red, sand, tan, titanium, and white. The RANGER vehicles have three or six seats and the ProXD vehicles have two or four seats. The RANGER and ProXD vehicles have "POLARIS" stamped on the front grille. The model number and VIN are printed on a portion of the left rear frame (on the driver's side of the vehicle) under the cargo box.
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
This recall involves 1/2 fl. oz (15 mL) amber glass bottles with black caps of deSensua Wintergreen Essential Oil, Birch Essential Oil and Pain Soother Essential Oil. The black, gold and blue labels on each bottle displays the deSensua logo, product name and the volume amount of the bottle. The Wintergreen Essential Oil has UPC code 760921403266, the Birch Essential Oil has UPC code 760921403129 and the Pain Soother Essential Oil has UPC code 760921403051 printed on the back of the label.