Recall D-0848-2022
Description: 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
Recall D-0848-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0848-2022 |
Event ID | 89986 |
Distribution | Nationwide in the United States including Guam and the Northern Mariana Islands. |
Quantity | 81,757 bottles |
Recall Reason | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. |
Drug Classification | Class II |
Drug Code Info | 20220511 |
Recall Initiation Date | 20220421 |
Report Date | 20220511 |
Classification Date | 20220505 |
Address | 4853 Crumpler Rd Memphis, TN 38141-8301 United States |
Recalling Firm | McKesson Corporation dba McKesson Drug Company |
Initial Notification | Letter |
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