November 2020 FDA Recall Regenecare Ha by Mpm Medical Llc
D-0118-2021 - Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

This Class I drug recall was voluntarily initiated by Mpm Medical Llc on November 17, 2020 for the product Regenecare Ha. The FDA reported the reason for recall as microbial contamination of non-sterile drug product. the product was found to be contaminated with the bacteria burkholderia cepecia.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0118-2021

Reason for Recall
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Initiated
11-17-2020
Reported
12-09-2020
Quantity
7,637 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86767
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MPM Medical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-08-2022
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lot: 41262 Exp. 01/21

Affected Packages Involved in this Recall

66977-107-03 Regenecare Ha
66977-107-04 Regenecare Ha
66977-107-05 Regenecare Ha