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

FDA recall notice · announced December 9, 2020 · Mpm Medical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: 41262 Exp. 01/21
Quantity: 7,637 tubes
Status: Terminated
Products in this recall event:
- 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 (D-0118-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.