BETAMETHASONE DIPROPIONATE Recall D-0850-2022
Description: Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram 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 63739-996-65
BETAMETHASONE DIPROPIONATE Recall D-0850-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0850-2022 |
| Event ID | 89986 |
| Brand | BETAMETHASONE DIPROPIONATE |
| Generic Name | BETAMETHASONE DIPROPIONATE |
| Manufacturer | BETAMETHASONE DIPROPIONATE |
| Original Package? | 1 |
| Active Substance | BETAMETHASONE DIPROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the United States including Guam and the Northern Mariana Islands. |
| Quantity | 55,440 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 | 63739-996 |
| 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 | 826Y60901U |
| Drug Application Number | ANDA206118 |
| Structured Product Labeling (SPL ID) | 2e6365d8-cbee-42dd-b919-373edf1ce243 |
| Structured Product Labeling (SPL Set ID) | 51530f90-6587-494d-8059-610820fa5d0b |
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