The Recall Desk
SevereFDA (Drugs)·D-0885-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Smoke Control Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Smoke Control bottles due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Illness, injury, or structural failure has been reported. 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 severity score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling 262 bottles of Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-3031-2 and UPC 357955303022.

The recall covers specific lots: 091015N with an expiration date of 09/18, and 111716H with an expiration date of 11/19. The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955303022, NDC 57955-3031-2
Manufacturer
King Bio Inc.
Category
Drug — Topical / Ophthalmic
Hazard
Affected units
262

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 (2)

  • Lots: 091015N Exp. 09/18
  • 111716H Exp. 11/19

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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Same hazard · microbial contamination

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