Drugplain

DOCUSATE SODIUM 100 mg/1

DOCUSATE SODIUM · CAPSULE, LIQUID FILLED · PD-Rx Pharmaceuticals, Inc.

10 Recalls on Record
Plain English

DOCUSATE SODIUM is a capsule, liquid filled containing docusate sodium at 100 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..

Key Facts

Brand Name
DOCUSATE SODIUM
Generic Name
DOCUSATE SODIUM
NDC Code (Product)
72789-399
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Strength
100 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
11/15/2022

Recall History

10 Recalls on Record
Class II05/31/2019

Geritrex, LLC

cGMP Deviations: Products may have microbial contamination.

TerminatedVoluntary: Firm initiated
Class II08/16/2017

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7

TerminatedVoluntary: Firm initiated
Class II08/08/2016

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class III10/01/2019

Sato Pharmaceutical Inc.

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

TerminatedVoluntary: Firm initiated
Class II01/16/2019

Rx Pak Division of McKesson Corporation

Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.

TerminatedVoluntary: Firm initiated
Class I07/15/2016

The Harvard Drug Group

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

TerminatedVoluntary: Firm initiated
Class III02/29/2016

Allegiant Health

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

TerminatedVoluntary: Firm initiated
Class II08/02/2017

The Harvard Drug Group

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is DOCUSATE SODIUM used for?

DOCUSATE SODIUM contains DOCUSATE SODIUM. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is DOCUSATE SODIUM a controlled substance?

DOCUSATE SODIUM is not classified as a controlled substance by the DEA.

What is the generic name for DOCUSATE SODIUM?

The generic name for DOCUSATE SODIUM is DOCUSATE SODIUM. There are 11 other brand versions of DOCUSATE SODIUM.

What is the NDC code for DOCUSATE SODIUM 100 mg/1?

The NDC (National Drug Code) for DOCUSATE SODIUM 100 mg/1 is 72789-399, listed by PD-Rx Pharmaceuticals, Inc..