RecallRadar

FDA Drug recall D-0603-2017

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

On 2017-03-22 the FDA classified a Class III recall of Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product… by Pharmedium Services, citing labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0603-2017
ClassificationClass III
Statusterminated
Initiated2017-01-27
Published2017-03-22
Last updated2026-09-13 11:51 UTC
CompanyPharmedium Services
DistributionUS

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

Reason

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

Identifiers

code_infoLot Numbers: 170110030M, 170110029M and 170070058M

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0603-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.