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oxymetazoline FDA Alerts

The FDA Alert(s) below may be specifically about oxymetazoline or relate to a group or class of drugs which include oxymetazoline.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for oxymetazoline

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Aug 28, 2018

Audience: Consumer, Health Professional, Pharmacy

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. This recall should be carried out to the retail level.

Risk Statement: Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, including babies or very young children. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date.

The additional nasal and baby oral gel products included as part of this expanded recall are listed below in Attachment A. The products can be identified by checking the item code, product description, lot #, and expiration date, as listed below in Attachment A.

Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase.

Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at 704-939-4342, Monday through Friday from 8 am to 4 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Attachment A

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Aug 8, 2018

Audience: Consumer, Health Professional, Pharmacy

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

Risk Statement: Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or  immuno-compromised. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall.

The product is used as a nasal decongestant and is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton. 16,896 units were released with UPC code 50428432365.  The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is Lot # 173089J, EXP 09/19. The product can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health on top left. The IFC containing the bottle is also orange and contains the same wording.  Lot 173089J and EXP 09/19 is coded on the side panel of the carton. Product was distributed Nationwide to retail outlets.

Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase or discard the product.

Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 am to 4 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

Zicam Extreme Congestion Relief Nasal Gel: Recall - Contamination With Burkholderia Cepacia

Dec 19, 2012

Audience: Consumer

ISSUE: Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.

Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs.

The affected lot is 2J23, Expiration 09/15.

BACKGROUND: The product is a non-drip liquid nasal gel used as a nasal decongestant and is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing NDC number 62750-005-10. The product was distributed to retailers nationwide throughout the United States.

RECOMMENDATION: Matrixx is notifying its distributors and retail customers by FEDEX letter and by phone and is arranging for return of all recalled products. Consumers that have the affected lot of Zicam Extreme Congestion Relief nasal gel should stop using the product and contact Matrixx. See the Press Release for additional information. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/18/2012 - Press Release - Matrixx Initiatives]

Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children

Oct 25, 2012

Audience: Pediatrics, Consumer

ISSUE: FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children.

BACKGROUND: Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach. These products are sold under various brand names, as generics, and as store brands (see List of Products, included in the Drug Safety Communication, below).

RECOMMENDATION: Consumers should store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant spray, call the National Capital Poison Center (1-800-222-1222) and seek emergency medical care immediately.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[10/25/2012 - Drug Safety Communication - FDA]
[10/25/2012 - List of Products - FDA]
[10/25/2012 - Consumer Update: Drops, Sprays Put Curious Kids at Risk - FDA]
 

Major Twice-A-Day 12 Hour Nasal Spray

Mar 26, 2004

Audience: Pharmacists and consumers

Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-Day 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was contaminated with Burkholderia cepacia bacteria. This product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%. The entire lot was distributed nationwide to wholesalers, pharmacies, hospitals and retailers. Use of this contaminated product could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis. The lot number and expiration date are found on the bottom of the carton and the back of the bottle label.

[UPDATE March 26, 2004 Press Release - Propharma]
[March 18, 2004 Press Release - Propharma]

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