King Bio Recalls GynePlex Vaginal Gel Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx GynePlex vaginal gel because of microbial contamination. The product was distributed in the U.S., Canada, and Australia.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
King Bio Inc. is voluntarily recalling 95 bottles of Dr. King's SafeCare Rx GynePlex, a 2 fl. oz. (59 mL) vaginal gel. The recall is being conducted due to microbial contamination. The affected product is identified by NDC 57955-0007-2 and UPC 357955000723.
The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. Two specific lots are affected: Lot 091015F with an expiration date of 09/18, and Lot 100416C with an expiration date of 10/19.
Consumers who have purchased this product should stop using it immediately 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 GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000723, NDC 57955-0007-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Vaginal Gel
- Hazard
- Affected units
- 95
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: 091015F Exp. 09/18
- 100416C Exp. 10/19
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.
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