Drug recall
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by…
FDA recall event 88850 · Class I, Class II · Teligent Pharma, Inc.
Key facts
| Event ID | 88850 |
|---|---|
| Recall numbers | D-0279-2022, D-0280-2022, D-0281-2022 |
| Recalling firm | Teligent Pharma, Inc. |
| Product type | Drugs |
| Products | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky…, Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50 |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent., Superpotent Drug |
| Initiation date | Oct 12, 2021 |
| Report date | Dec 22, 2021 |
| Termination date | Jun 18, 2024 |
| City | Buena |
| State | NJ |
| Country | United States |
| FEI number | 1000526875 |
At a glance
- 1–9 Products in this recall
- 10–99 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: