The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0761-2019·Announced 2019-03-20

FDA Recalls King Bio Headache Drops for Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Headache Freee drops due to microbial contamination. The affected 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 source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's SafeCare Rx Headache Freee drops, 2 fl. oz. (59 mL), manufactured by King Bio Inc. The recall is due to microbial contamination. The affected product is identified by UPC 357955015321 and NDC 57955-0153-2.

The recall covers 438 bottles with the following lot numbers and expiration dates: 022516D (Exp. 02/19), 080916A (Exp. 08/19), and 121317K (Exp. 12/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should stop using it immediately and contact King Bio Inc. or their healthcare provider for further instructions. The FDA classifies this as a Class I recall, which is the most serious type of recall, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Headache Freee... U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955015321 NDC 57955-0153-2
Manufacturer
King Bio Inc.
Category
Drug — Topical/OTC
Hazard
Affected units
438

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 (3)

  • Lots: 022516D Exp. 02/19
  • 080916A Exp. 08/19
  • 121317K Exp. 12/19

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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