The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0847-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx First Aid for Mind & Body

King Bio Inc. is recalling Dr. King's SafeCare Rx First Aid for Mind & Body due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a reasonable probability that use of the product may cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling 1,229 bottles of Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by NDC 57955-1770-2 and UPC 357955177029.

The affected lots are 072815Q (Exp. 07/18), 081815E (Exp. 08/18), 091216F (Exp. 09/19), and 071317A (Exp. 07/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955177029, NDC 57955-1770-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic / OTC
Hazard
Affected units
1,229

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lots: 072815Q Exp. 07/18
  • 081815E Exp. 08/18
  • 091216F Exp. 09/19
  • 071317A Exp. 07/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 465 products in this recall →

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