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Recall Observatory FDA recall evidence

Drug product

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .

D-0041-2019

August 03, 2018

Class II

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class II
Quantity
182,568 bottles
Official record key
drug-enforcement:D-0041-2019

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