Regenecare Ha Gel
FDA Recall NDC 66977-107
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Regenecare Ha (NDC 66977-107). A significant event, classified as Class I, was initiated on Nov 17, 2020 by Mpm Medical Llc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2020 Class I Recall: Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Recall Number
Class I Terminated
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Nov 17, 2020
Dec 09, 2020
7,637 tubes
Recall Profile & Regulatory Data
Event ID
86767
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
MPM Medical LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Sep 08, 2022
Product Description
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
66977-107-03Product
66977-107-04Product
66977-107-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
