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Recall Observatory FDA recall evidence

Drug product

Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955750123, NDC 57955-7501-2

D-0745-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
268 bottles
Official record key
drug-enforcement:D-0745-2019

Official wording

Reason: Microbial contamination

Code information: Lots: 070815J Exp. 07/18; 091015G Exp. 09/18; 021216F Exp. 02/19; 052616M Exp. 05/19; 083016A Exp. 08/19

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination