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Recall Observatory FDA recall evidence

Drug product

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.

D-0074-2019

August 03, 2018

Class I

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class I
Quantity
16 bottles
Official record key
drug-enforcement:D-0074-2019

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

Code information: Lot: 173089J Exp. 09/19

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination