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Recall 2019-012: Solco - Irbesartan - NYC - Consumer


URGENT!!!            DRUG RECALL!!!            URGENT!!!
 

Description Lot #     Exp Date    NDC    UPC
IRBES/HCTZ TB150/12.5MGSOLC30@ 325D18005 3/31/2021 43547033003 34354733003
  325D18004 3/31/2021    
IRBESARTAN TAB 300MG SOLC 90@ 331B18009 2/28/2021 43547037609 34354737609
IRBESART-HCTZ300/12.5MGSOLC30@ 327A18002 3/31/2021 43547033103 34354733103
  327A18001 3/31/2021    
IRBESART-HCTZ300/12.5MGSOLC90@ 327B18009 3/31/2021 43547033109 34354733109
  327B18008 3/31/2021    
IRBES-HCTZ CP 150/12.5MGSOL90@ 325B18004 3/31/2021 43547033009 34354733009


Solco Healthcare is voluntarily recalling the above items/lots due to the detection of trace amount on an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.  This recall is to the Consumer level.  Affected product started shipping July 10, 2018.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication, until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

This recall is being conducted with the knowledge of the FDA.


Contact:

Stericycle: Stericycle Solco Healthcare 888-871-7116