Agency classClass IIOur severity:Severe FDA (Drugs)·D-0550-2017·Announced 2017-03-22

Synergy Rx Recalls ACNE SOLUTION Due to Sterility Assurance Issues

Synergy Rx is recalling ACNE SOLUTION, a prescription topical medication, due to a lack of assurance of sterility and 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with lack of sterility assurance.

Plain-English summary

Synergy Rx is recalling ACNE SOLUTION, a prescription-only topical medication containing salicylic acid, hydrocortisone, niacinamide, azelaic acid, and clindamycin. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

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

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: ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%, Clindamycin 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer: Synergy Rx
Category: Drug — Topical Prescription
Hazard: sterility
cgmp-deviation

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 →

Same manufacturer · Synergy Rx

See all →

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Severe
Synergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
High
Synergy Rx Modified Jessner Peel Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
Severe
Synergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22

Same hazard · sterility