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RISEDRONATE SODIUM Recall D-0762-2022

Description: Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

RISEDRONATE SODIUM Recall D-0762-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0762-2022
Event ID89766
BrandRISEDRONATE SODIUM
Generic NameRISEDRONATE SODIUM
ManufacturerRISEDRONATE SODIUM
Original Package?1
Active SubstanceRISEDRONATE SODIUM
Drug RouteORAL
DistributionUSA Nationwide
Quantity4872 bottles
Recall ReasonFAILED CONTENT UNIFORMITY SPECIFICATIONS
Drug ClassificationClass III
Drug Code Info20220413
Product NDC33342-107 33342-108 33342-109
Recall Initiation Date20220310
Report Date20220413
Classification Date20220407
Address666 Plainsboro Rd Bldg 200 Ste 230
Plainsboro, NJ 08536-0009
United States
Recalling FirmMacleods Pharma Usa Inc
Initial Notification Letter
Unique Ingredient IdentifierOFG5EXG60L
Drug Application NumberANDA203533
Structured Product Labeling (SPL ID)4607af24-13bd-474e-8488-1a73488af3e2
Structured Product Labeling (SPL Set ID)62aff8d6-a2f7-4c7e-a102-c70105ac3792
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