The Recall Desk
SevereFDA (Drugs)·D-0591-2017·Announced 2017-03-22

Synergy Rx Recalls Purified Water Due to Sterility Assurance Concerns

Synergy Rx is recalling all lots of Purified Water due to a lack of assurance of sterility and CGMP deviations.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, or high-risk pathogens without reported illness.

Plain-English summary

Synergy Rx is recalling all lots of Purified Water, a prescription-only product. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The product was distributed nationwide within the United States. The source text does not specify the exact number of units affected or specific lot numbers, indicating that all lots are included in this recall.

Consumers and healthcare providers should stop using the recalled product and contact Synergy Rx for further instructions or a refund.

The recalled product

Product
PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 81 recalled by Synergy Rx 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 81 products in this recall →