REGENECARE HA Topical Anesthetic Hydrogel recalled over sterility concerns

Recall date

November 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MPM Medical LLC recalls REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesqu…

Recall number

D-0118-2021

FDA classification

Class I

Brand / firm

MPM Medical LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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