The Recall Desk
SevereFDA (Drugs)·D-0565-2017·Announced 2017-03-22

Synergy Rx Recalls LTP Ophthalmic Solution Due to Sterility Concerns

Synergy Rx is recalling LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%) ophthalmic solution nationwide 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 the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of serious injury or infection.

Plain-English summary

Synergy Rx is recalling LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), a prescription-only ophthalmic solution, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.

The product was distributed nationwide within the United States. The recall applies to all lots of the product.

Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx
Category
Drug — Ophthalmic Solution
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 →

Related recalls

Same manufacturer · Synergy Rx

See all →

Same hazard · sterility

See all →