Drugplain

G-1 1 [hp_X]/mL

ABIES ALBA LEAFY TWIG · SOLUTION · DNA Labs, Inc.

10 Recalls on Record
Plain English

G-1 is a solution containing abies alba leafy twig at 1 [hp_X]/mL, taken sublingual. Manufactured by DNA Labs, Inc..

Key Facts

Brand Name
G-1
Generic Name
ABIES ALBA LEAFY TWIG
NDC Code (Product)
58264-0364
Manufacturer
DNA Labs, Inc.
Strength
1 [hp_X]/mL
Dosage Form
SOLUTION
Route
SUBLINGUAL
Marketing Status
Marketing Start
01/01/1990

Recall History

10 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II08/02/2021

Akorn, Inc.

Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class III03/29/2021

Teligent Pharma, Inc.

Failed Stability Specifications: product did not meet viscosity results.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II10/13/2022

Akorn, Inc.

CGMP Deviations:

OngoingVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class III07/29/2021

Teligent Pharma, Inc.

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

TerminatedVoluntary: Firm initiated
Class II08/31/2022

Akorn, Inc.

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Late growth, fracture consolidation.

Dosage & Administration

SUGGESTED DOSAGE One dropper full twice daily.

Warnings

Warnings Use only if cap seal is unbroken. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of the reach of children.

Frequently Asked Questions

What is G-1 used for?

G-1 contains ABIES ALBA LEAFY TWIG. It is a solution taken sublingual. Consult your doctor for specific uses.

Is G-1 a controlled substance?

G-1 is not classified as a controlled substance by the DEA.

What is the generic name for G-1?

The generic name for G-1 is ABIES ALBA LEAFY TWIG. There are 1 other brand versions of ABIES ALBA LEAFY TWIG.

What is the NDC code for G-1 1 [hp_X]/mL?

The NDC (National Drug Code) for G-1 1 [hp_X]/mL is 58264-0364, listed by DNA Labs, Inc..

Product NDC

58264-0364

Package NDC

58264-0364-2

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

Data from openFDA · Public domain (CC0 1.0)