The Recall Desk
SevereFDA (Drugs)·D-0127-2019·Announced 2018-11-07

Aurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity

Aurobindo Pharma is recalling Irbesartan bulk active ingredient because N-Nitrosodimethylamine (NDEA), a carcinogen, was detected. The product was distributed to one customer in New York.

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: The recall is classified as FDA Class II and involves the presence of NDEA, a carcinogen, which poses a significant health risk.

Plain-English summary

Aurobindo Pharma Limited (Unit I) is recalling 1,724.8 kilograms of Irbesartan Bulk Active Pharmaceutical Ingredient. The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation where N-Nitrosodimethylamine (NDEA), a known carcinogen impurity, was detected in the active ingredient.

The affected product was distributed to one customer located in New York. The recall covers specific manufacturing and dispatch batch numbers with expiration dates ranging from December 2018 to November 2020.

Consumers and healthcare providers should check their inventory for the specific batch numbers listed in the official recall notice. If the product is found, it should be quarantined and returned to the supplier or disposed of according to FDA guidelines. No specific instructions for end-users are provided in the source text as the product is a bulk ingredient.

The recalled product

Product
Irbesartan Bulk Active Pharmaceutical Ingredient.
Manufacturer
Aurobindo Pharma Limited (Unit I)
Category
Drug — Bulk Active Pharmaceutical Ingredient
Hazard

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 (20)

  • Manufacturing batch numbers: 1601100782
  • dispatch batch number 1601101589
  • exp. date 12/01/2018 1601100783
  • dispatch batch number 1601101590
  • exp. date 12/01/2018 1701111861
  • dispatch batch number 1701113404
  • exp. date 09/01/2020 1701112170
  • dispatch batch number 1701113405
  • exp. date 09/01/2020 1701112501
  • dispatch batch number 1701113406
  • exp. date 09/01/2020 1701112056
  • dispatch batch number 1701113407
  • exp. date 09/01/2020 1701112558
  • dispatch batch number 1701114283
  • exp. date 10/01/2020 1701112559
  • dispatch batch number 1701114285
  • exp. date 10/01/2020 1701112589
  • dispatch batch number 1701114286
  • exp. date 10/01/2020 1701113300
  • dispatch batch number 1701114289

Distribution

Distributed in 1 state:

Related recalls

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