The Recall Desk
SevereFDA (Drugs)·D-1069-2018·Announced 2018-08-15

Guardian Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

Guardian Pharmacy Services is recalling 250 syringes of Lidocaine 3% in Texas due to a lack of sterility assurance.

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 sterility assurance, which poses a risk of serious injury or infection.

Plain-English summary

Guardian Pharmacy Services is recalling 250 10-mL syringes of Lidocaine 3% (Rx Only) in Texas. The recall was initiated because of a lack of sterility assurance for the compounded product.

The affected lots are 58641:42 (Use By: 06/04/2018), 58775:42 (Use By: 06/16/2018), and 59077:42 (Use By: 07/17/2018). The product was distributed in Texas.

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

The recalled product

Product
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

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 (3)

  • Lots: 58641:42 Use By: 06/04/2018
  • 58775:42 Use By: 06/16/2018
  • 59077:42 Use By: 07/17/2018

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 23 recalled by Guardian Pharmacy Services 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 23 products in this recall →