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BARRIER THERAPY RECALL STATEMENT

The Prequel Team is announcing that, out of an abundance of caution, we are voluntarily recalling four lots of Barrier Therapy Skin Protectant Cream.

Due to the possibility of bacterial contamination, we have initiated a product recall for only the following lots: X4054A, X4136A, X4137A, X4138A.  Lot numbers are located on the back of the tube (see below).  No other lots or any other prequel products are a part of or affected by this recall.

Customers who purchased the product with the designated lot numbers should discontinue use and discard the product.

We are disappointed in any concerns or inconvenience this situation causes. Our customers' safety, health, and welfare come first.

We recently became aware of a potential issue with one of our manufacturing partners’ testing processes and results and immediately began an investigation. We brought in independent experts and are conducting additional testing through a third-party laboratory. 

We are working with our retail partner to return specific lot codes of product from their shelves and warehouses to be replaced with new product as soon as it is available.

While we have not received reports of adverse events from customers with respect to this product and believe the potential of an adverse reaction is incredibly rare, this bacteria (Staphylococcus saprophyticus) has the potential to cause skin irritation or infection.

If you purchased Barrier Therapy with one of the lot codes listed above, please return it for a full refund.  See “Information On Refunds” below for instructions on how to do so.

FREQUENTLY ASKED QUESTIONS

Why did you do a recall?

We recently became aware of a potential issue with one of our manufacturing partner’s testing processes and results and immediately began an investigation. Out of an abundance of caution and with the knowledge of the U.S. Food and Drug Administration, we have initiated a voluntary product recall for four lots of Barrier Therapy.

Due to the possibility of bacterial contamination, we have initiated a product recall for only the following lots: X4054A, X4136A, X4137A, X4138A. Lot numbers are located on either the front or back of the tube (see below). No other lots or any other Prequel products are a part of or affected by this recall.

Where do I find the lot code on my Barrier Therapy?

The lot code is located on either the front or back of the tube along the top crimp (where the tube is sealed). The lot code will begin with the letter “X”.

Should I worry if I have already used this product?

While we have not received reports of adverse events from customers with respect to this product and believe the potential of an adverse reaction is incredibly low, the bacteria potentially found in the four affected lots (X4054A, X4136A, X4137A, X4138A) may cause skin irritation or infection. If you are currently using Barrier Therapy from one of the affected lots, please discontinue use and discard.

When will Barrier Therapy be back in stock?

We are working diligently to get Barrier Therapy back in stock. Click here to join the waitlist

INFORMATION ON REFUNDS

For orders on Prequelskin.com

Please email customer service at barriertherapy@prequelskin.com with your order number and a photo of your lot code (see above for how to find lot code).

For orders on TikTok Shop

Please email customer service at barriertherapy@prequelskin.com with your order number and a photo of your lot code (see above for how to find lot code).

For orders from a retailer.

Please follow the return instructions on the retailer website or return it back to one of their stores. They will be providing refunds for returned products with proof of purchase.

MORE RECALL QUESTIONS

Can I keep using my Barrier Therapy?

If you are using Barrier Therapy from one of the affected lots (X4054A, X4136A, X4137A, X4138A), please discontinue use and discard.

Were other batches of Barrier Therapy affected?

No, only four lots were affected (X4054A, X4136A, X4137A, X4138A). If you have a Barrier Therapy tube from a different lot, you may continue using it.

What are you doing to make sure this doesn't happen in the future?

We are reviewing our Manufacturing Compliance Monitoring Protocol to ensure ongoing adherence to meet our rigorous quality standards. 

What does bacterial contamination mean?

The presence of any pathogens above regulated levels is considered a contamination. Every product we produce is quality tested prior to offering it for sale to ensure presence of bacteria, yeast, or mold species are at minimum levels, as regulated by required quality and safety guidelines. 

Aren’t preservatives supposed to prevent bacteria from growing?

Preservatives are meant to maintain the integrity of a product over time.  During formulation, Barrier Therapy passed a standardized testing procedure called Preservative Efficacy Test (PET) to ensure the effectiveness of the preservative. That being said, the use of preservatives cannot guarantee that unique environmental contamination will not occur.  

Are other PREQUEL products safe to use?

Yes, PREQUEL products are formulated to optimize skin health. The only product affected by this recall is Barrier Therapy (lots X4054A, X4136A, X4137A, X4138A).

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