The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0547-2017·Announced 2017-03-22

Synergy Rx Recalls Hydroquinone Cream Due to Sterility Assurance Issues

Synergy Rx is recalling Hydroquinone Cream in all strengths 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 (4) according to the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Synergy Rx is recalling Hydroquinone Cream in all strengths, including 4%, 5%, 6%, 7%, and 8%, as well as Hydroquinone 5%/Kojic Acid 3% Cream. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected products are prescription-only (Rx only) and were distributed nationwide within the United States. The recall covers all lots of the specified products.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm, Synergy Rx, for further instructions.

The recalled product

Product
HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC ACID 3% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx
Category
Drug — Topical Cream
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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