The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0540-2017·Announced 2017-03-22

Synergy Rx Recalls Glycolic Acid Solution Due to Sterility Concerns

Synergy Rx is recalling all strengths of Glycolic Acid Solution because the product lacks assurance of sterility and has CGMP deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, and the source text explicitly states 'Lack of Assurance of Sterility,' which aligns with the rubric criterion for Severe severity involving significant injury risks or Class II classifications with serious health implications.

Plain-English summary

Synergy Rx is recalling all strengths of Glycolic Acid Solution, including 10%, 20%, 30%, 50%, and 60%, which are prescription-only products. The recall was initiated because the product lacks assurance of sterility and involves Current Good Manufacturing Practice (CGMP) deviations.

The affected products were distributed nationwide within the United States. The recall covers all lots of the product. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx
Category
Drug — Topical Solution
Hazard

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 →

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