The Recall Desk
CriticalFDA (Drugs)·D-0772-2019·Announced 2019-03-20

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

King Bio Inc. is recalling Dr. King's SafeCare Rx CS-Rectal Bowel products due to microbial contamination. The recall affects 94 bottles 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 has classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is voluntarily recalling 94 bottles of Dr. King's SafeCare Rx CS-Rectal Bowel, 2 fl. oz. (59 mL). The recall is being conducted because the product is subject to microbial contamination.

The affected product is identified by NDC 57955-0218-2 and UPC 357955021827. Specific lots involved in the recall include 022616F (Exp. 02/19), 080217A (Exp. 08/19), and 060716K (Exp. 06/19). The products were distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx CS-Rectal Bowel, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021827, NDC 57955-0218-2
Manufacturer
King Bio Inc.
Category
Drug — Rectal Preparation
Hazard
Affected units
94

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: 022616F Exp. 02/19
  • 080217A Exp. 08/19
  • 060716K 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 →

Related recalls

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Same hazard · microbial contamination

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