Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teligent Pharma, Inc., originally initiated on 10-12-2021 for the product 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 The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0281-2022 | 10-12-2021 | 12-22-2021 | Class II | 14,664 glass bottles | 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 | 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. | Terminated |
| D-0280-2022 | 10-12-2021 | 12-22-2021 | Class I | 52,104 glass bottles | 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 | Superpotent Drug | Terminated |
| D-0279-2022 | 10-12-2021 | 12-22-2021 | Class II | 7,008 glass bottles | 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 Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64. | 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. | Terminated |
Recalled Products
