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Recall Observatory FDA recall evidence

Drug product

Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.

D-0080-2019

August 03, 2018

Class II

Product summary

Firm
Product Quest Manufacturing LLC
Event
Event 80750
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0080-2019

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

Field note

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