Drugplain

Quality Choice 625 mg/1

Calcium Polycarbophil · TABLET, FILM COATED · QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)

10 Recalls on RecordCurrently in Shortage
Plain English

Quality Choice is a tablet, film coated containing calcium polycarbophil at 625 mg/1, taken oral. Manufactured by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION).

Key Facts

Brand Name
Quality Choice
Generic Name
Calcium Polycarbophil
NDC Code (Product)
63868-530
Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Strength
625 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
04/16/2019

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class III01/04/2022

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II11/26/2013

Humco Holding Group, Inc

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

TerminatedVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class III12/04/2014

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.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II12/28/2023

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.

OngoingVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class III04/15/2014

P&L Developments, LLC

Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

TerminatedVoluntary: Firm initiated
Class II03/20/2026

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.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue53,937 reports
drug ineffective45,517 reports
nausea44,554 reports
off label use42,784 reports
dyspnoea42,703 reports
diarrhoea40,383 reports
pain37,278 reports
headache35,206 reports
dizziness32,685 reports
vomiting29,221 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Calcium Polycarbophil. It is a tablet, film coated taken oral. 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 Calcium Polycarbophil. There are 12 other brand versions of Calcium Polycarbophil.

What is the NDC code for Quality Choice 625 mg/1?

The NDC (National Drug Code) for Quality Choice 625 mg/1 is 63868-530, listed by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION).