PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: May 11, 2022 Initiated: April 21, 2022 #D-0849-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
1176 tubes
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by McKesson Corporation dba McKesson Drug Company. Units affected: 1176 tubes.
Why was this product recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0849-2022.