The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0532-2017·Announced 2017-03-22

Synergy Rx Recalls Betamethasone Creams and Ointments for Sterility Concerns

Synergy Rx is recalling various betamethasone cream and ointment products 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Synergy Rx is recalling multiple prescription-only betamethasone cream and ointment products, including BL 20%/4% Cream and various BLT combinations. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected products were distributed nationwide within the United States. The recall covers all lots of the listed products. No specific illness or injury reports are mentioned in the source text.

Consumers and healthcare providers should stop using these products and contact Synergy Rx or their healthcare provider for further instructions.

The recalled product

Product
BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%…
Manufacturer
Synergy Rx
Category
Drug — Topical Steroids
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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