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Recall Observatory FDA recall evidence

Drug product

CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.

D-0035-2019

August 03, 2018

Class II

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class II
Quantity
552 bottles
Official record key
drug-enforcement:D-0035-2019

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