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Recall Observatory FDA recall evidence

Drug product

Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.

D-0064-2019

August 03, 2018

Class II

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class II
Quantity
533,016 bottles
Official record key
drug-enforcement:D-0064-2019

Official wording

Reason: CGMP Deviations: products manufactured under conditions that could impact its product quality.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations