Drugplain

Glycerin 1 g/1.21

Glycerin · SUPPOSITORY · CVS Pharmacy

10 Recalls on Record
Plain English

Glycerin is a suppository containing glycerin at 1 g/1.21, taken rectal. Manufactured by CVS Pharmacy.

Key Facts

Brand Name
Glycerin
Generic Name
Glycerin
NDC Code (Product)
69842-722
Manufacturer
CVS Pharmacy
Strength
1 g/1.21
Dosage Form
SUPPOSITORY
Route
RECTAL
Marketing Status
Application #
M007
Drug Class
Non-Standardized Chemical Allergen [EPC]
Marketing Start
08/18/2016

Recall History

10 Recalls on Record
Class II02/12/2015

Health Innovations Pharmacy, Inc

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

TerminatedVoluntary: Firm initiated
Class II08/12/2019

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II10/07/2022

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

OngoingVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated
Class II06/13/2023

K.C. Pharmaceuticals, Inc

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

OngoingVoluntary: Firm initiated
Class II09/26/2012

New England Compounding Center

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/26/2019

Medtech Products, Inc.

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

pain1,941 reports
drug ineffective1,827 reports
infusion related reaction1,799 reports
off label use1,671 reports
glossodynia1,634 reports
pemphigus1,613 reports
hand deformity1,604 reports
joint swelling1,600 reports
rash1,593 reports
impaired healing1,586 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for relief of occasional constipation this product generally produces a bowel movement in 1/4 to 1 hour

Dosage & Administration

Directions Single daily dosage children 2 to under 6 years 1 suppository or as directed by a doctor children under 2 years ask a doctor Insert suppository well up intorectum. Suppository need not melt completely to produce laxative action.

Warnings

Warnings For rectal use only May cause rectal discomfort of burning sensation Ask a Doctor before using laxative if child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than two weeks already used a laxative for more than 1 week Stop use and consult a doctor if child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Glycerin used for?

Glycerin contains Glycerin. It is a suppository taken rectal. Consult your doctor for specific uses.

Is Glycerin a controlled substance?

Glycerin is not classified as a controlled substance by the DEA.

What is the generic name for Glycerin?

The generic name for Glycerin is Glycerin. There are 12 other brand versions of Glycerin.

What is the NDC code for Glycerin 1 g/1.21?

The NDC (National Drug Code) for Glycerin 1 g/1.21 is 69842-722, listed by CVS Pharmacy.