The Recall Desk
SevereFDA (Drugs)·D-0090-2022·Announced 2021-11-10

Lupin Pharmaceuticals Irbesartan/Hydrochlorothiazide Tablets Recalled for Impurity

Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.

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 a Class II drug recall involving a CGMP deviation with detection of a nitrosamine impurity (N-nitrosoirbesartan) in a cardiovascular medication. Although no illnesses or hospitalizations are explicitly reported in the source text, Class II recalls with manufacturing deviations affecting distributed pharmaceuticals are classified as Severe per the rubric.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg, in two package sizes: 30-count bottles (NDC 68180-414-06) and 90-count bottles (NDC 68180-414-09). The recall was issued because impurity N-nitrosoirbesartan was detected in the active pharmaceutical ingredient, a deviation from current Good Manufacturing Practice (CGMP) requirements.

A total of 98,052 bottles were distributed to major distributors, who may have further distributed the product nationwide. The affected lots and expiration dates are listed in the recall notice and include lot numbers H804192, H805348, H900065, H902264 (for 30-count bottles) and lot numbers H804082, H804121, H804338, H804538, H804539, H805349, H805350, H900066, H900067, H902265, H902275, H902276, H902531, and H902532 (for 90-count bottles), with expiration dates ranging from August 2021 through May 2022.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without medical advice.

The recalled product

Product
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Hypertension / Cardiovascular
Hazard
  • nitrosamine-impurity
  • cgmp-deviation

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 (19)

  • a) Lot# H804192
  • exp. date 31/08/2021 H805348
  • exp. date 30/11/2021 H900065
  • exp. date 31/12/2021 H902264
  • exp. date 31/05/2022 b) Lot# H804082
  • exp. date 31/08/2021 H804121
  • exp. date 31/08/2021 H804338
  • exp. date 31/08/2021 H804538
  • exp. date 30/09/2021 H804539
  • exp. date 30/09/2021 H805349
  • exp. date 30/11/2021 H805350
  • exp. date 30/11/2021 H900066
  • exp. date 31/12/2021 H900067
  • exp. date 31/12/2021 H902265
  • exp. date31/05/2022 H902275
  • exp. date31/05/2022 H902276
  • exp. date31/05/2022 H902531
  • exp. date 30/04/2022 H902532
  • exp. date 30/04/2022

Distribution

Distributed nationwide across the United States.

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