The Recall Desk
SevereFDA (Drugs)·D-0089-2022·Announced 2021-11-10

Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination

Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving CGMP deviations that resulted in detection of a potentially harmful impurity (N-nitrosoirbesartan, a known or suspected carcinogen) in a prescription medication. Although no illnesses or hospitalizations are reported in the source text, Class II recalls with manufacturing defects and chemical contaminants in drugs warrant a Severe rating per the rubric.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg in two package sizes: 30-count bottles (NDC 68180-413-06) and 90-count bottles (NDC 68180-413-09). A total of 63,408 bottles are affected by this recall.

The recall was initiated because the active pharmaceutical ingredient (API) in these tablets was found to contain the impurity N-nitrosoirbesartan. This contamination resulted from current good manufacturing practice (CGMP) deviations in the manufacturing process.

The affected product was distributed to major distributors who may have further distributed it nationwide. Affected lots and expiration dates are detailed in the recall notice. Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without consulting their healthcare provider.

The recalled product

Product
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Hypertension Medication
Hazard
  • impurity-contamination
  • nitrosamine

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • a) Lot# H804537
  • exp. date 30/09/2021 H805148
  • exp. date 31/10/2021 H900063
  • exp. date 31/10/2021 H900522
  • exp. date 31/12/2021 H901582
  • exp. date 31/01/2022 b) Lot# H000963
  • exp. date 30/04/2022 H804507
  • exp. date 30/04/2022 H804536
  • exp. date 30/09/2021 H805070
  • exp. date 31/10/2021 H805149
  • exp. date 31/10/2021 H900064
  • exp. date 31/12/2021 H900523
  • exp. date 31/01/2022 H901583
  • exp. date 30/04/2022 H902530
  • exp. date 30/04/2022

Distribution

Distributed nationwide across the United States.

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