The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0863-2019·Announced 2019-03-20

Dr. King's SafeCare Rx CS-Lymph Hodgkins is being recalled due to microbial contamination

The FDA is recalling Dr. King's SafeCare Rx CS-Lymph Hodgkins because of microbial contamination. Consumers should stop using the product immediately.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Even though the specific microbial contaminant is not named, the presence of a Class I classification ensures the severity cannot be lower than 4.

Plain-English summary

The FDA is recalling Dr. King's SafeCare Rx CS-Lymph Hodgkins (2 fl. oz.) due to microbial contamination. Affected batches include Lot Numbers 080315F (expired 08/18) and 121916B (expired 12/19) distributed across the United States, Canada, and Australia. The recall is initiated because microbial contamination poses a potential health risk associated with the product's formulation. Consumers are advised to discontinue use of this product immediately and seek medical attention if they experience any adverse effects. The manufacturer, King Bio Inc., has issued recall number D-0863-2019.

No specific pathogens were identified in the source text beyond the general statement of microbial contamination. The recall is classified under FDA Class I, which triggers a minimum severity rating of 4 according to the severity rubric. Because the agency designates this as a Class I recall, the severity cannot be lower than 4 regardless of additional hazard details.

Consumers should return unused product to the retailer for proper disposal or follow the manufacturer's guidance for safe disposal. The product quantity involved was 85 bottles. The recall covers both domestic and international markets including the U.S., Canada, and Australia.

The recalled product

Product
Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021520, NDC 57955-0215-2
Manufacturer
King Bio Inc.
Category
Drug — Prescription
Hazard
Affected units
85

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: 080315F Exp. 08/18
  • 121916B 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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