Product Safety Recalls

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ERYTHROMYCIN Recall D-0851-2022

Description: Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68

ERYTHROMYCIN Recall D-0851-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0851-2022
Event ID89986
BrandERYTHROMYCIN
Generic NameERYTHROMYCIN
ManufacturerERYTHROMYCIN
Original Package?1
Active SubstanceERYTHROMYCIN
Drug RouteTOPICAL
DistributionNationwide in the United States including Guam and the Northern Mariana Islands.
Quantity5,640 tubes
Recall ReasonCGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220511
Product NDC63739-053
Product NUIN0000009982 N0000175877 N0000175935
Pharma Class (PE)Decreased Sebaceous Gland Activity [PE]
Pharma Class (EPC)Macrolide [EPC]
Pharma Class (CS)Macrolides [CS]
Recall Initiation Date20220421
Report Date20220511
Classification Date20220505
Address4853 Crumpler Rd
Memphis, TN 38141-8301
United States
Recalling FirmMcKesson Corporation dba McKesson Drug Company
Initial Notification Letter
Unique Ingredient Identifier63937KV33D
Drug Application NumberANDA208154
Structured Product Labeling (SPL ID)c706f1d7-6bdd-41b3-a458-64dc442e355e
Structured Product Labeling (SPL Set ID)59d21d19-b45d-435d-8899-667d46f90ea3
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