The Recall Desk
SevereFDA (Drugs)·D-0568-2017·Announced 2017-03-22

Synergy Rx Recalls QUAD PEEL Due to Sterility Assurance Concerns

Synergy Rx is recalling QUAD PEEL chemical peels nationwide 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 rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a topical chemical peel.

Plain-English summary

Synergy Rx is voluntarily recalling all lots of QUAD PEEL, a prescription-only chemical peel product containing Sal Acid 2%, TCA 7%, Phenol 7%, and Retinoic acid 0.4%. The recall is being conducted because the product lacks assurance of sterility and the manufacturer has identified Current Good Manufacturing Practice (CGMP) deviations.

The affected product was distributed nationwide within the United States. The recall covers all lots of the product. No specific dates or quantities are provided in the source text.

Consumers and healthcare providers with this product should stop using it and contact Synergy Rx at (855) 792-6676 for further instructions or a refund.

The recalled product

Product
QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), 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 →