Nasal Solution 1 g/100mL
Nasal Solution · LIQUID · Bullet Point LLC
Nasal Solution is a liquid containing nasal solution at 1 g/100mL, taken nasal. Manufactured by Bullet Point LLC.
Key Facts
- Brand Name
- Nasal Solution
- Generic Name
- Nasal Solution
- NDC Code (Product)
84008-101- Manufacturer
- Bullet Point LLC
- Strength
- 1 g/100mL
- Dosage Form
- LIQUID
- Route
- NASAL
- Marketing Status
- Application #
- 505G(a)(3)
- Drug Class
- Antiseptic [EPC]
- Marketing Start
- 02/20/2024
Recall History
Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Edge Pharma, LLC
CGMP Deviations
Seaway Pharma Inc.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Apotex Corp.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Roxane Laboratories, Inc.
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
ENDO USA, Inc.
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Montana Compounding Pharmacy
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Ingenus Pharmaceuticals Llc
Out of specification for related substances (impurities).
Edge Pharma, LLC
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses: *Congested nose andsinuses. *lrritated and itchy nose. *Nasal exposure to bacteria,dust and other airbornecontaminants.
Dosage & Administration
Directions: Adults and children over 6years of age: 1 spray in eachnostril not more than 3times in any 24-hour period,Children under é years ofage: Consult a doctor. For the frst time -Removesafety seal and original capfrom bottle. insert dip tubeinto bottle, and screw on. Gently blow your nose toclear the nasal passageway.Shake the product well,remove the cap, and thenspray it quickly and frmlyup your nostril. Do not tilt your headbackward during sprayingAfter use, wipe the spraynozzle clean and securelyreattach the cap.
Warnings
Use of container bymore than one person canspread infection.
Frequently Asked Questions
What is Nasal Solution used for?
Nasal Solution contains Nasal Solution. It is a liquid taken nasal. Consult your doctor for specific uses.
Is Nasal Solution a controlled substance?
Nasal Solution is not classified as a controlled substance by the DEA.
What is the generic name for Nasal Solution?
The generic name for Nasal Solution is Nasal Solution. There are no other listed brand versions of Nasal Solution.
What is the NDC code for Nasal Solution 1 g/100mL?
The NDC (National Drug Code) for Nasal Solution 1 g/100mL is 84008-101, listed by Bullet Point LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)