Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product description
Irbesartan Bulk Active Pharmaceutical Ingredient.
Lot numbers, UPCs & expiration codes
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, exp. date 10/01/2020 1701113301, dispatch batch number 1701114291, exp. date 10/01/2020 1701113302, dispatch batch number 1701114708, exp. date 10/01/2020 1701113312, dispatch batch number 1701114709, exp. date 10/01/2020 1701115460, dispatch batch number 1701117039, exp. date 11/01/2020 1701115974, dispatch batch number 1701117040, exp. date 11/01/2020 1701115460, dispatch batch number 1701117041, exp. date 11/01/2020 1701115738, dispatch batch number 1701117042, exp. date 11/01/2020 1701115739, dispatch batch number 1701117043, exp. date 11/01/2020 1701115740, dispatch batch number 1701117044, exp. date 11/01/2020 1701115741, dispatch batch number 1701117045, exp. date 11/01/2020 1701115742, dispatch batch number 1701117046, exp. date 11/01/2020
Where it was sold
Product was distributed to one customer in NY.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0127-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 1724.8 kgs.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma Limited (Unit I)
Original FDA data
Every field from FDA enforcement report D-0127-2019, exactly as published.
Show all FDA fields
- City
- Arutla
- Status
- Terminated
- Country
- India
- Event ID
- 81442
- Address
- 385 386 Bulk Active Plant
- Address (line 2)
- Unit I; Survey 379
- Code information
- 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, exp. date 10/01/2020 1701113301, dispatch batch number 1701114291, exp. date 10/01/2020 1701113302, dispatch batch number 1701114708, exp. date 10/01/2020 1701113312, dispatch batch number 1701114709, exp. date 10/01/2020 1701115460, dispatch batch number 1701117039, exp. date 11/01/2020 1701115974, dispatch batch number 1701117040, exp. date 11/01/2020 1701115460, dispatch batch number 1701117041, exp. date 11/01/2020 1701115738, dispatch batch number 1701117042, exp. date 11/01/2020 1701115739, dispatch batch number 1701117043, exp. date 11/01/2020 1701115740, dispatch batch number 1701117044, exp. date 11/01/2020 1701115741, dispatch batch number 1701117045, exp. date 11/01/2020 1701115742, dispatch batch number 1701117046, exp. date 11/01/2020
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0127-2019
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma Limited (Unit I)
- Product quantity
- 1724.8 kgs.
- Termination date
- Mar 27, 2020
- Reason for recall
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irbesartan Bulk Active Pharmaceutical Ingredient.
- Distribution pattern
- Product was distributed to one customer in NY.
- Recall initiation date
- Oct 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 31, 2018