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Recall Observatory FDA recall evidence

Drug product

ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.

D-1494-2019

June 21, 2019

Class II

Product summary

Firm
Pharma-Natural Inc.
Event
Event 83190
Status
Terminated
Classification
Class II
Quantity
4981 roll on bottles
Official record key
drug-enforcement:D-1494-2019

Official wording

Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Code information: All lots remaining within expiry.

Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations

Field note

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