Quality Choice 10 mg/g
Hydrocortisone · CREAM · Chain Drug Marketing Association, Inc.
Quality Choice is a cream containing hydrocortisone at 10 mg/g, taken topical. Manufactured by Chain Drug Marketing Association, Inc..
Key Facts
- Brand Name
- Quality Choice
- Generic Name
- Hydrocortisone
- NDC Code (Product)
83324-297- Manufacturer
- Chain Drug Marketing Association, Inc.
- Strength
- 10 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 01/06/2025
Recall History
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Humco Holding Group, Inc
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Vi-Jon, LLC
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
K C Pharmaceuticals Inc
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Seaway Pharma Inc.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
P&L Developments, LLC
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use for the relief of • pressure, bloating, and fullness commonly referred to as gas
Dosage & Administration
Directions • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Warnings
Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Frequently Asked Questions
What is Quality Choice used for?
Quality Choice contains Hydrocortisone. It is a cream taken topical. Consult your doctor for specific uses.
Is Quality Choice a controlled substance?
Quality Choice is not classified as a controlled substance by the DEA.
What is the generic name for Quality Choice?
The generic name for Quality Choice is Hydrocortisone. There are 11 other brand versions of Hydrocortisone.
What is the NDC code for Quality Choice 10 mg/g?
The NDC (National Drug Code) for Quality Choice 10 mg/g is 83324-297, listed by Chain Drug Marketing Association, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)