Drug 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
D-0118-2021
Product summary
- Firm
- MPM Medical LLC
- Event
- Event 86767
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,637 tubes
- Official record key
drug-enforcement:D-0118-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Code information: Lot: 41262 Exp. 01/21
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination