The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0564-2017·Announced 2017-03-22

Synergy Rx Recalls Malek's Magic Plus Due to Sterility Concerns

Synergy Rx is recalling Malek's Magic Plus prescription cream because it 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the lack of sterility assurance in a prescription product.

Plain-English summary

Synergy Rx is recalling all lots of Malek's Magic Plus, a prescription topical cream containing retinoic acid, hydroquinone, kojic acid, and hydrocortisone. The product was distributed nationwide within the United States.

The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. These issues indicate that the manufacturing process did not meet the required standards for ensuring the product's safety and quality.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone 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

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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