The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0525-2017·Announced 2017-03-22

Synergy Rx Recalls Ketoconazole and Hydrocortisone Cream Due to Sterility Concerns

Synergy Rx is recalling all lots of Ketoconazole 2%/Hydrocortisone 1.5% Cream 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant manufacturing deviations like lack of sterility assurance.

Plain-English summary

Synergy Rx is recalling all lots of Ketoconazole 2%/Hydrocortisone 1.5% Cream, a prescription-only topical medication. The recall was initiated because the product lacks assurance of sterility and is associated with Current Good Manufacturing Practice (CGMP) deviations.

The recalled product was distributed nationwide within the United States. The source text does not specify the exact number of units affected or the specific dates of distribution.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.
Manufacturer
Synergy Rx
Category
Drug — Topical Prescription 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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