FDA Recall D-0697-2019

King Bio Inc. · Asheville, NC

Class I — life-threatening Terminated 1279 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream High Potency Homeopathic Formula for Professional Use Only, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 USA, UPC 357955730132, NDC 57955-7301-3

Lot / code: Lots: 010517ZZ Exp. 01/20; 030818ZZ Exp. 03/21; 040617ZZ Exp. 04/20; 100616ZZ Exp. 05/19; 110916ZZ Exp. 11/19

Quantity: 3536 tubes

Reason for recall

Microbial contamination

Recall record

Recall number: D-0697-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: U.S.A. Nationwide, Canada, and Australia.
Recall initiated: 2018-07-20
Classified by FDA Center: 2019-03-08
FDA published: 2019-03-20
Terminated: 2022-01-19
Recalling firm: King Bio Inc.
Firm location: Asheville, NC

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