Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Reason Lack of Assurance of Sterility
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.