Summary Company Announcement Date: October 23, 2020
FDA Publish Date: October 23, 2020
Product Type: Food & Beverages Fish Allergens Reason for Announcement: Recall Reason Description Undeclared wheat and milk
Company Name: Orca Bay Foods, LLC Brand Name: Brand Name(s) Trader Joe’s
Product Description: Product Description Gluten Free Battered Halibut
Company Announcement Orca Bay Foods of Seattle, WA is recalling 4,450 lb. (356 cases) of 10 oz. retail box Trader Joe’s brand Gluten Free Battered Halibut SKU 00503822, because it contains undeclared wheat and milk allergens. People who have an allergy or severe sensitivity to wheat and milk run the…

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12.1 Mechanism of Action

Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

12.2 Pharmacodynamics

The insulinotropic response to a meal is enhanced with glipizide extended-release tablets administration in diabetic patients. The postprandial insulin and C-peptide responses continue to be enhanced after at least 6 months of treatment. In two randomized, double-blind, dose-response studies comprising a total of 347 patients, there was no significant increase in fasting insulin in all glipizide extended-release tablets-treated patients combined compared to placebo, although…

Oxygen, Refrigerated Liquid, USP UN1073

Rx ONLY

Rx ONLY. WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction of resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDER, CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBELS IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. Do not handle until all safety precautions have been read and understood. Keep and store…

NITROUS OXIDE USP
UN1070
Rx Only. WARNING: Administration of Nitrous Oxide may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrous Oxide and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves…

OXYGEN
COMPRESSED
USP
UN 1072
DANGER:
MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 °c (125 °F)….

DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts. The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements. The drug labeling information on this Web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. These labels have been reformatted to make them easier to read. …

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to…

The following adverse reactions are described, or described in greater detail, in other sections of the labeling:

Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1)]
Other extrapyramidal effects [see Warnings and Precautions (5.2)]
Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
Depression [see Warnings and Precautions (5.4)]
Hypertension [see Warnings and Precautions (5.5)]
Fluid retention [see Warnings and Precautions (5.6)]
Hyperprolactinemia [see Warnings and Precautions (5.7)]
Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8)]

The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common…

Water (Aqua), Triethanolamine, Carbomer, Aloe Bardadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (Cl 16035), FD & C Yellow 6 (Cl 15985), FD& C Violet 2 (Cl 60725), FD& C Blue 1 (Cl 42090), FD & C Yellow 5 (Cl 19140), FD& C Red 33 (Cl 17200). …