Drugplain

Cottonseed .1 g/mL

Cottonseed · INJECTION · Allermed Laboratories, Inc.

5 Recalls on Record
Plain English

Cottonseed is a injection containing cottonseed at .1 g/mL, taken cutaneous. Manufactured by Allermed Laboratories, Inc..

Key Facts

Brand Name
Cottonseed
Generic Name
Cottonseed
NDC Code (Product)
49643-005
Manufacturer
Allermed Laboratories, Inc.
Strength
.1 g/mL
Dosage Form
INJECTION
Route
CUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Marketing Status
Application #
BLA102211
Marketing Start
03/12/1974

Recall History

5 Recalls on Record
Class II09/03/2015

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

TerminatedVoluntary: Firm initiated
Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II07/13/2023

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II05/25/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II07/24/2019

Colonia Care Pharmacy

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Cottonseed used for?

Cottonseed contains Cottonseed. It is a injection taken cutaneous. Consult your doctor for specific uses.

Is Cottonseed a controlled substance?

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

What is the generic name for Cottonseed?

The generic name for Cottonseed is Cottonseed. There are no other listed brand versions of Cottonseed.

What is the NDC code for Cottonseed .1 g/mL?

The NDC (National Drug Code) for Cottonseed .1 g/mL is 49643-005, listed by Allermed Laboratories, Inc..

Product NDC

49643-005

Package NDC

49643-005-05

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)