Drug recall
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05)…
FDA recall event 83538 · Class II · Ridge Properties, LLC
Key facts
| Event ID | 83538 |
|---|---|
| Recall numbers | D-1856-2019, D-1857-2019, D-1858-2019, D-1859-2019, D-1860-2019, D-1861-2019 |
| Recalling firm | Ridge Properties, LLC |
| Product type | Drugs |
| Products | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed…, PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured…, Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain…, Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by…, Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay., Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. |
| Initiation date | Aug 9, 2019 |
| Report date | Sep 25, 2019 |
| Termination date | Jul 12, 2023 |
| City | Salem |
| State | OR |
| Country | United States |
| FEI number | 3011007272 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: