Recalls / Class III

Class IIID-0603-2017

Product

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

Affected lot / code info

Lot Numbers: 170110030M, 170110029M and 170070058M

Why it was recalled

Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Recalling firm

Firm

Pharmedium Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity

3879 syringes

Distribution pattern

Nationwide

Timeline

Recall initiated

2017-01-27

FDA classified

2017-03-15

Posted by FDA

2017-03-22

Terminated

2017-03-16

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0603-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.