Recalls / Class I
Class ID-0118-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Regenecare Ha
- Generic name
- Lidocaine Hcl
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Topical
- NDC
- 66977-107
- FDA application
- M017
- Affected lot / code info
- Lot: 41262 Exp. 01/21
Why it was recalled
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Recalling firm
- Firm
- MPM Medical LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1801 Big Town Blvd Ste 300, N/A, Mesquite, Texas 75149-1030
Distribution
- Quantity
- 7,637 tubes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-17
- FDA classified
- 2020-12-07
- Posted by FDA
- 2020-12-09
- Terminated
- 2022-09-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0118-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.