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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0851-2022 |
| Event ID | 89986 |
| Brand | ERYTHROMYCIN |
| Generic Name | ERYTHROMYCIN |
| Manufacturer | ERYTHROMYCIN |
| Original Package? | 1 |
| Active Substance | ERYTHROMYCIN |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the United States including Guam and the Northern Mariana Islands. |
| Quantity | 5,640 tubes |
| 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 |
| Product NDC | 63739-053 |
| Product NUI | N0000009982 N0000175877 N0000175935 |
| Pharma Class (PE) | Decreased Sebaceous Gland Activity [PE] |
| Pharma Class (EPC) | Macrolide [EPC] |
| Pharma Class (CS) | Macrolides [CS] |
| 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 |
| Unique Ingredient Identifier | 63937KV33D |
| Drug Application Number | ANDA208154 |
| 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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