PlainRecalls
FDA Drug Moderate Class II Terminated

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reported: May 1, 2019 Initiated: April 12, 2019 #D-1223-2019

Product Description

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for Recall

Lack of sterility assurance.

Details

Recalling Firm
CMC Enterprise Pharmacy
Units Affected
1135 syringes
Distribution
NC
Location
Charlotte, NC

Frequently Asked Questions

What product was recalled?
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.. Recalled by CMC Enterprise Pharmacy. Units affected: 1135 syringes.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2019. Severity: Moderate. Recall number: D-1223-2019.