The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0909-2019·Announced 2019-03-20

King Bio Recalls AsthmaCare Homeopathic Product Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Safecare+ AsthmaCare Homeopathic bottles due to microbial contamination. The product is 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling 190,189 bottles of Dr. King's Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL). The recall is due to microbial contamination. The product is identified by UPC 357955404422 and NDC 57955-4044-1.

The affected lots include 122216K, 120217P, 111117C, 083116C, 082316E, 072015A, 062716C, 062316B, 062218C, 052218C, 052118C, 051716J, 041816C, 030316A, 022317H, 111516H, 091815A, 062718C, and 081815A. These lots have expiration dates ranging from 03/19 to 06/20.

The product was distributed nationwide in the U.S.A., as well as in Canada and Australia. Consumers should stop using the product and contact King Bio Inc. for a refund or further instructions.

The recalled product

Product
Dr. King's Safecare+ AsthmaCare Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC 357955404422, NDC 57955-4044-1
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
190,189

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 (19)

  • Lots: 122216K Exp. 12/19
  • 120217P Exp. 12/19
  • 111117C Exp. 11/19
  • 083116C Exp. 08/19
  • 082316E Exp. 08/19
  • 072015A Exp. 07/18
  • 062716C Exp. 06/19
  • 062316B Exp. 06/19
  • 062218C Exp. 06/20
  • 052218C Exp. 05/20
  • 052118C Exp. 05/20
  • 051716J Exp. 05/19
  • 041816C Exp. 04/19
  • 030316A Exp. 03/19
  • 022317H Exp. 02/20
  • 111516H Exp. 11/19
  • 091815A Exp. 09/18
  • 062718C Exp. 06/20
  • 081815A Exp. 08/18

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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