FDA recall D-0118-2021

Product

REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03

Reason for recall

Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-11-17

Report date

2020-12-09

Termination date

2022-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mesquite, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2021