FDA-Drug2020-12-09Class I
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
MPM Medical LLC
Hazard
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Sold states
Distributed Nationwide in the USA
Affected count
7,637 tubes
Manufactured in
1801 Big Town Blvd Ste 300, N/A, Mesquite, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2021Don't want to check this manually?
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