The Recall Desk
CriticalFDA (Drugs)·D-0898-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx CS-Ovary Due to Microbial Contamination

King Bio Inc. is recalling 26 bottles of Dr. King's SafeCare Rx CS-Ovary 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 source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

King Bio Inc. is recalling 26 bottles of Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0216-2 and UPC 357955021629. Specific lots involved are 123115A (expiring 12/18) and 122216J (expiring 12/19).

The recall covers distribution across the United States, Canada, and Australia. The U.S. Food and Drug Administration has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Consumers who possess the affected product should stop using it and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021629, NDC 57955-0216-2
Manufacturer
King Bio Inc.
Affected units
26

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: 123115A Exp. 12/18
  • 122216J 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 →