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Recall Observatory FDA recall evidence

Drug product

SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.

D-1348-2016

April 20, 2016

Class II

Product summary

Firm
Murray International Trading Co., Inc.
Event
Event 74017
Status
Terminated
Classification
Class II
Quantity
144 bottles
Official record key
drug-enforcement:D-1348-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.

Code information: All lots

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.