Product Recall: CVS Health 12 Hour Sinus Relief Nasal Mist - MedWaste Management Product Recall: CVS Health 12 Hour Sinus Relief Nasal Mist - MedWaste Management

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Product Recall: CVS Health 12 Hour Sinus Relief Nasal Mist

CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid in a spray bottle with a nozzle that fits up your nostril, is having problems with lot number 173089J. There was microbiological contamination in that lot. The microbe contamination was identified as Pseudomonas aeruginosa.

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. 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 box has the same colors and words on it. On the side panel of the carton, the affected lot would have the words: “Lot 173089J” and “EXP 09/19” coded on it.

The nasal decongestant is packaged in 0.5 fluid ounce bottles, in individual folding carton.

Product was distributed Nationwide to retail outlets.

 Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening.

Infection is usually benign, but in certain patient populations, such as those with cystic fibrosis or  immuno-compromised.

The company has not received any reports of adverse events related to this recall.

So far, anyways.

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.

  • Complete and submit the report Onlinefda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm 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.

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