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
Reported: December 9, 2020 Initiated: November 17, 2020 #D-0118-2021
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
Reason for Recall
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Details
- Recalling Firm
- MPM Medical LLC
- Units Affected
- 7,637 tubes
- Distribution
- Distributed Nationwide in the USA
- Location
- Mesquite, TX
Frequently Asked Questions
What product 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. Recalled by MPM Medical LLC. Units affected: 7,637 tubes.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Critical. Recall number: D-0118-2021.
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