Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to major distributors who may have further distributed the product nationwide.
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-0089-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 12, 2021
- FDA report date
- Nov 10, 2021
- Quantity
- 63,408 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0089-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 88856
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- 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
- Postal code
- 21202-6174
- Report date
- Nov 10, 2021
- Product type
- Drugs
- Recall number
- D-0089-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 63,408 bottles
- Termination date
- Jan 30, 2023
- Reason for recall
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to major distributors who may have further distributed the product nationwide.
- Recall initiation date
- Oct 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2021