The Recall Desk
CriticalFDA (Drugs)·D-0793-2019·Announced 2019-03-20

King Bio Recalls Heartburn Relief for Microbial Contamination

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

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is recalling 245 bottles of Dr. King's SafeCare Rx Heartburn Relief, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The affected product has the NDC 57955-0022-2 and UPC 357955002222.

The recalled lots are 041416B (Exp. 04/19) and 091416K (Exp. 09/19). 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 further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Heartburn Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002222, NDC 57955-0022-2
Manufacturer
King Bio Inc.
Category
Drug — OTC Heartburn Relief
Hazard
Affected units
245

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: 041416B Exp. 04/19
  • 091416K Exp. 09/19

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 →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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