PharMEDium Recalls Subpotent Buffered Lidocaine HCl Syringes Nationwide

Plain-English summary

PharMEDium Services, LLC. is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate). The affected products are available in two configurations: 1 mL in 3 mL BD Syringes and 5 mL in 5 mL BD Syringes, both sold in cartons of 10. The recall was initiated on January 2, 2019, and was classified as Class II by the FDA.

The reason for the recall is that the product was found to be subpotent, meaning it contained less of the active ingredient than labeled. The affected lots are identified by Service Codes 2K2466 and 2K2470, along with specific NDC codes listed in the recall documentation. The products were distributed throughout the United States.

Consumers and healthcare providers should check their inventory for the specific service codes and NDC numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer. The recall status is currently terminated.

The recalled product

Product

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land,

Manufacturer

PharMEDium Services, LLC.

Category

Drug — Injectable Anesthetic

Hazard

• subpotent-drug

Affected units

7,711

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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