Drugplain

colchicine .6 mg/1

colchicine · TABLET · Bryant Ranch Prepack

6 Recalls on Record
Plain English

colchicine is a tablet containing colchicine at .6 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
colchicine
Generic Name
colchicine
NDC Code (Product)
71335-1738
Manufacturer
Bryant Ranch Prepack
Strength
.6 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA209876
Drug Class
Alkaloid [EPC]
Marketing Start
06/11/2020

Recall History

6 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 II12/18/2024

Granules Pharmaceuticals Inc.

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

TerminatedVoluntary: Firm initiated
Class III02/24/2023

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

diarrhoea2,343 reports
off label use2,126 reports
drug ineffective1,983 reports
nausea1,759 reports
fatigue1,582 reports
arthralgia1,324 reports
dyspnoea1,324 reports
acute kidney injury1,286 reports
headache1,235 reports
toxicity to various agents1,222 reports

Frequently Asked Questions

What is colchicine used for?

colchicine contains colchicine. It is a tablet taken oral. Consult your doctor for specific uses.

Is colchicine a controlled substance?

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

What is the generic name for colchicine?

The generic name for colchicine is colchicine. There are 8 other brand versions of colchicine.

What is the NDC code for colchicine .6 mg/1?

The NDC (National Drug Code) for colchicine .6 mg/1 is 71335-1738, listed by Bryant Ranch Prepack.