The Recall Desk
SevereFDA (Drugs)·D-0771-2019·Announced 2019-03-20

FDA Recalls Dr. King's SafeCare Rx PMS Relief Due to Microbial Contamination

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling 180 bottles of Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0095-2 and UPC 357955000921.

The affected lots are 082316A (Expiration 08/19) and 022916E (Expiration 02/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If found, they should stop using the product and contact the manufacturer or a healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000921, NDC 57955-0095-2
Manufacturer
King Bio Inc.
Category
Drug — Topical / OTC
Hazard
Affected units
180

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: 082316A Exp. 08/19
  • 022916E Exp. 02/19

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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