Why it was recalled
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
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
Lot numbers, UPCs & expiration codes
Lot: 41262 Exp. 01/21
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0118-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 7,637 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MPM Medical LLC
Original FDA data
Every field from FDA enforcement report D-0118-2021, exactly as published.
Show all FDA fields
- City
- Mesquite
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86767
- Address
- 1801 Big Town Blvd Ste 300
- Code information
- Lot: 41262 Exp. 01/21
- Postal code
- 75149-1030
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0118-2021
- Classification
- Class I
- Recalling firm
- MPM Medical LLC
- Product quantity
- 7,637 tubes
- Termination date
- Sep 8, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 7, 2020