METFORMIN HYDROCHLORIDE Recall D-0746-2022
Description: Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03)
METFORMIN HYDROCHLORIDE Recall D-0746-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0746-2022 |
| Event ID | 89893 |
| Brand | JANUMET |
| Generic Name | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Manufacturer | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | METFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 3600 cartons |
| Recall Reason | Presence of foreign substance: Presence of stainless steel particulates in tablets. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 0006-0575 0006-0577 |
| Drug UPC | 0300060577611 0300060575617 |
| Recall Initiation Date | 20220331 |
| Report Date | 20220413 |
| Classification Date | 20220405 |
| Address | 1 Merck Dr Whitehouse Station, NJ 08889-3400 United States |
| Recalling Firm | MERCK SHARP & DOHME CORP |
| Initial Notification | Letter |
| Unique Ingredient Identifier | TS63EW8X6F 786Z46389E |
| Drug Application Number | NDA022044 |
| Structured Product Labeling (SPL ID) | 53efa1d9-741f-4546-82e3-a7806ac8cfea |
| Structured Product Labeling (SPL Set ID) | d19c7ed0-ad5c-426e-b2df-722508f97d67 |
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