FDA Drug recall D-0848-2022
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc
- FDA Drug
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc by Mckesson, citing CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0848-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-21 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson |
| Distribution | US |
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Identifiers
| code_info | Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 0…Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0848-2022%22
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