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Recall Observatory FDA recall evidence

Drug product

B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735

D-1149-2014

July 22, 2013

Class I

Product summary

Firm
Mira Health Products Ltd.
Event
Event 65772
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-1149-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug

Code information: Lot numbers: C02R and F03Q

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug