FDA Drug recall D-0279-2022
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ…
- FDA Drug
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ… by Teligent Pharma, citing 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 s….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0279-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-12 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| ndc | 63739-997-64 |
|---|---|
| code_info | Lot #: 16306, Exp. Date 01/2024. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0279-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.