Skip to content
Recall Observatory FDA recall evidence

Drug product

Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66

D-0849-2022

April 21, 2022

Class II

Product summary

Firm
McKesson Corporation dba McKesson Drug Company
Event
Event 89986
Status
Ongoing
Classification
Class II
Quantity
1176 tubes
Official record key
drug-enforcement:D-0849-2022

Official wording

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Code information: Lot: 16876, Exp.: 05/31/2023

Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations