Drugplain

Cottonseed .001 g/mL

Gossypium hirsutum · SOLUTION · Greer Laboratories, Inc.

5 Recalls on Record
Plain English

Cottonseed (Gossypium hirsutum) is an over-the-counter intradermal solution used for allergy testing to help identify cotton seed allergies. It is administered by injection into the skin to observe allergic reactions.

Key Facts

Brand Name
Cottonseed
Generic Name
Gossypium hirsutum
NDC Code (Product)
22840-1554
Manufacturer
Greer Laboratories, Inc.
Strength
.001 g/mL
Dosage Form
SOLUTION
Route
INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Marketing Status
Application #
BLA101833
Marketing Start
09/15/1981

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 (Gossypium hirsutum) is an over-the-counter intradermal solution used for allergy testing to help identify cotton seed allergies. It is administered by injection into the skin to observe allergic reactions.

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 Gossypium hirsutum. There are 4 other brand versions of Gossypium hirsutum.

What is the NDC code for Cottonseed .001 g/mL?

The NDC (National Drug Code) for Cottonseed .001 g/mL is 22840-1554, listed by Greer Laboratories, Inc..

Product NDC

22840-1554

Package NDC

22840-1554-1

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

Data from openFDA · Public domain (CC0 1.0)