FDA Recall D-0118-2021
MPM Medical LLC · Mesquite, TX
Class I — life-threatening Terminated 660 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0118-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2020-11-17
- Classified by FDA Center
- 2020-12-07
- FDA published
- 2020-12-09
- Terminated
- 2022-09-08
- Recalling firm
- MPM Medical LLC
- Firm location
- Mesquite, TX
Drug identification
- Brand name(s)
- REGENECARE HA
- Generic name(s)
- LIDOCAINE HCL
- Manufacturer(s)
- MPM Medical LLC
- NDC(s)
66977-107- Route(s)
- TOPICAL