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Recall Observatory FDA recall evidence

Drug product

Dr. King's Acute Pain Relief Cooling Topical, 89 mL (topical cream), Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80074489 UPC 357955181439

D-0959-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
192 tubes
Official record key
drug-enforcement:D-0959-2019

Official wording

Reason: Microbial contamination

Code information: Lot: 020417ZZ Exp. 02/20

Distribution pattern: U.S.A. Nationwide, Canada, and Australia.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination