Synergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues
Synergy Rx is recalling various lidocaine cream and ointment products nationwide due to a 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in medical products.
Plain-English summary
Synergy Rx is recalling Lidocaine Cream in all strengths, including 5%, 8%, 23%, and 30%, as well as specific combinations with prilocaine, melylephrine, tetracaine, and phenylephrine in cream and ointment forms. The recall covers all lots of these prescription-only products, which were 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 guarantee the products were sterile as required.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for guidance on alternatives or further instructions.
The recalled product
- Product
- LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Anesthetic
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.
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