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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0746-2022
Event ID89893
BrandJANUMET
Generic NameSITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ManufacturerSITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Original Package?1
Active SubstanceMETFORMIN HYDROCHLORIDE SITAGLIPTIN PHOSPHATE
Drug RouteORAL
DistributionNationwide in the USA
Quantity3600 cartons
Recall ReasonPresence of foreign substance: Presence of stainless steel particulates in tablets.
Drug ClassificationClass II
Drug Code Info20220413
Product NDC0006-0575 0006-0577
Drug UPC0300060577611 0300060575617
Recall Initiation Date20220331
Report Date20220413
Classification Date20220405
Address1 Merck Dr
Whitehouse Station, NJ 08889-3400
United States
Recalling FirmMERCK SHARP & DOHME CORP
Initial Notification Letter
Unique Ingredient IdentifierTS63EW8X6F 786Z46389E
Drug Application NumberNDA022044
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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