The Recall Desk
SevereFDA (Drugs)·D-0536-2017·Announced 2017-03-22

Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues

Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.

What this means for you

Illness, injury, or structural failure has been reported. 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 and involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05%, prescription-only products, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.

The affected products were distributed nationwide within the United States. The recall covers all lots of the specified products.

Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal.

The recalled product

Product
ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx

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 →