D-0118-2021 Class I Terminated
FDA drug recall D-0118-2021 was initiated by MPM Medical LLC on November 17, 2020 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia. The recall status is terminated (terminated September 8, 2022). Affected quantity: 7,637 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- November 17, 2020
- Termination Date
- September 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,637 tubes
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot: 41262 Exp. 01/21