The Recall Desk
CriticalFDA (Drugs)·D-0818-2019·Announced 2019-03-20

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

King Bio Inc. is recalling 20 bottles of Dr. King's SafeCare Rx Immature 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 FDA classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) due to the reasonable probability of serious adverse health consequences.

Plain-English summary

King Bio Inc. is recalling 20 bottles of Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by Lot 060716J with an expiration date of 06/19. The NDC is 57955-2291-2 and the UPC is 357955229025.

The recall covers distribution in the U.S.A. Nationwide, Canada, and Australia. The FDA 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 should stop using the product and contact King Bio Inc. for instructions on return or disposal.

The recalled product

Product
Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955229025, NDC 57955-2291-2
Manufacturer
King Bio Inc.
Affected units
20

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 (1)

  • Lot: 060716J Exp. 06/19

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 →