Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product description
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot numbers, UPCs & expiration codes
Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001358 5/31/2022 68180-217-09 H001359 5/31/2022 68180-217-09 H001371 5/31/2022 68180-217-09 H001372 5/31/2022 68180-217-09 H001373 5/31/2022 68180-217-09 H001374 5/31/2022 68180-217-09 H001375 5/31/2022 68180-217-09 H001628 5/31/2022 68180-217-09 H001629 5/31/2022 68180-217-09 H001630 6/30/2022 68180-217-09 H001645 6/30/2022 68180-217-09 H001646 6/30/2022 68180-217-09 H001647 6/30/2022 68180-217-09 H001798 6/30/2022 68180-217-09 H001799 6/30/2022 68180-217-09 H001882 6/30/2022 68180-217-09 H001883 6/30/2022 68180-217-09 H001948 6/30/2022 68180-217-09 H001949 6/30/2022 68180-217-09 H001985 6/30/2022 68180-217-09 H001986 6/30/2022 68180-217-09 H001987 7/31/2022 68180-217-09 H001988 7/31/2022 68180-217-09 H001989 7/31/2022 68180-217-09 H001990 7/31/2022 68180-217-09 H002243 8/31/2022 68180-217-09 H002244 8/31/2022 68180-217-09 H002245 8/31/2022 68180-217-09 H002315 8/31/2022 68180-217-09 H002316 8/31/2022 68180-217-09 H002317 8/31/2022 68180-217-09 H002318 8/31/2022 68180-217-09 H002319 8/31/2022 68180-217-09 H002320 8/31/2022 68180-217-09 H002321 8/31/2022 68180-217-09 H002322 8/31/2022 68180-217-09 H002323 8/31/2022 68180-217-09 H002324 8/31/2022 68180-217-09 H002632 9/30/2022 68180-217-09 H002633 9/30/2022 68180-217-09 H002634 9/30/2022 68180-217-09 H002635 9/30/2022 68180-217-09 H002636 9/30/2022 68180-217-09 H002765 9/30/2022 68180-217-09 H002766 9/30/2022 68180-217-09 H002767 9/30/2022 68180-217-09 H002768 9/30/2022 68180-217-09 H002769 9/30/2022 68180-217-09 H002770 9/30/2022 68180-217-09 H003194 11/30/2022 68180-217-09 H003195 11/30/2022 68180-217-09 H100009 12/31/2022 68180-217-09 H100010 12/31/2022 68180-217-09 H100021 12/31/2022 68180-217-09 H100022 12/31/2022 68180-217-09 H100023 12/31/2022 68180-217-09 H100029 12/31/2022 68180-217-09 H100030 12/31/2022 68180-217-09 H100342 1/31/2023 68180-217-09 H100343 1/31/2023 68180-217-09 H100344 1/31/2023 68180-217-09 H100345 1/31/2023 68180-217-09 H100346 1/31/2023 68180-217-09 H100374 1/31/2023 68180-217-09 H100375 1/31/2023 68180-217-09 H100376 1/31/2023 68180-217-09 H100377 1/31/2023 68180-217-09 H100378 1/31/2023 68180-217-09 H100452 1/31/2023 68180-217-09 H100453 1/31/2023 68180-217-09 H100454 2/28/2023 68180-217-09 H100458 2/28/2023 68180-217-09 H100459 2/28/2023 68180-217-09 H100652 2/28/2023 68180-217-09 H100653 2/28/2023 68180-217-09 H100654 2/28/2023 68180-217-09 H100655 2/28/2023 68180-217-09 H100656 2/28/2023 68180-217-09 H100687 2/28/2023 68180-217-09 H100688 2/28/2023 68180-217-09 H100689 2/28/2023 68180-217-09 H100703 2/28/2023 68180-217-09 H100704 2/28/2023 68180-217-09 H100891 3/31/2023 68180-217-09 H100892 3/31/2023 68180-217-09 H100902 3/31/2023 68180-217-09 H100903 3/31/2023 68180-217-09 H100904 3/31/2023 68180-217-09 H100905 3/31/2023 68180-217-09 H100936 3/31/2023 68180-217-09 H100937 3/31/2023 68180-217-09 H100938 3/31/2023 68180-217-09 H101153 5/31/2023 68180-217-09 H101154 5/31/2023 68180-217-09 H101155 5/31/2023 68180-217-09 H101156 5/31/2023 68180-217-09 H101157 5/31/2023 68180-217-09 H101158 5/31/2023 68180-217-09 H101159 5/31/2023 68180-217-09 H101294 5/31/2023 68180-217-09 H101295 5/31/2023 68180-217-09 H101296 5/31/2023 68180-217-09 H101297 5/31/2023 68180-217-09 H101325 5/31/2023 68180-217-09 H101326 6/30/2023 68180-217-09 H101327 6/30/2023 68180-217-09 H101328 6/30/2023 68180-217-09 H101349 6/30/2023 68180-217-09 H101350 6/30/2023 68180-217-09 H101351 6/30/2023 68180-217-09 H101352 6/30/2023 68180-217-09 H101482 6/30/2023 68180-217-09 H101483 6/30/2023 68180-217-09 H101606 7/31/2023 68180-217-09 H101618 7/31/2023 68180-217-09 H101619 7/31/2023 68180-217-09 H101620 7/31/2023 68180-217-09 H101621 7/31/2023 68180-217-09 H101827 7/31/2023 68180-217-09 H101828 7/31/2023 68180-217-09 H101829 7/31/2023 68180-217-09 H101857 7/31/2023 68180-217-09 H101858 7/31/2023 68180-217-09 H101911 7/31/2023 68180-217-09 H101912 7/31/2023 68180-217-09 H101913 7/31/2023 68180-217-09 H102455 10/31/2023 68180-217-09 H102456 10/31/2023 68180-217-09 H102457 10/31/2023 68180-217-09 H102458 10/31/2023 68180-217-09 H102485 10/31/2023 68180-217-09 H102489 10/31/2023 68180-217-09 H102490 10/31/2023 68180-217-09 H102491 10/31/2023 68180-217-09
Where it was sold
Product was distributed 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-0842-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2022
- FDA report date
- May 11, 2022
- Quantity
- 303,696 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0842-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 89916
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001358 5/31/2022 68180-217-09 H001359 5/31/2022 68180-217-09 H001371 5/31/2022 68180-217-09 H001372 5/31/2022 68180-217-09 H001373 5/31/2022 68180-217-09 H001374 5/31/2022 68180-217-09 H001375 5/31/2022 68180-217-09 H001628 5/31/2022 68180-217-09 H001629 5/31/2022 68180-217-09 H001630 6/30/2022 68180-217-09 H001645 6/30/2022 68180-217-09 H001646 6/30/2022 68180-217-09 H001647 6/30/2022 68180-217-09 H001798 6/30/2022 68180-217-09 H001799 6/30/2022 68180-217-09 H001882 6/30/2022 68180-217-09 H001883 6/30/2022 68180-217-09 H001948 6/30/2022 68180-217-09 H001949 6/30/2022 68180-217-09 H001985 6/30/2022 68180-217-09 H001986 6/30/2022 68180-217-09 H001987 7/31/2022 68180-217-09 H001988 7/31/2022 68180-217-09 H001989 7/31/2022 68180-217-09 H001990 7/31/2022 68180-217-09 H002243 8/31/2022 68180-217-09 H002244 8/31/2022 68180-217-09 H002245 8/31/2022 68180-217-09 H002315 8/31/2022 68180-217-09 H002316 8/31/2022 68180-217-09 H002317 8/31/2022 68180-217-09 H002318 8/31/2022 68180-217-09 H002319 8/31/2022 68180-217-09 H002320 8/31/2022 68180-217-09 H002321 8/31/2022 68180-217-09 H002322 8/31/2022 68180-217-09 H002323 8/31/2022 68180-217-09 H002324 8/31/2022 68180-217-09 H002632 9/30/2022 68180-217-09 H002633 9/30/2022 68180-217-09 H002634 9/30/2022 68180-217-09 H002635 9/30/2022 68180-217-09 H002636 9/30/2022 68180-217-09 H002765 9/30/2022 68180-217-09 H002766 9/30/2022 68180-217-09 H002767 9/30/2022 68180-217-09 H002768 9/30/2022 68180-217-09 H002769 9/30/2022 68180-217-09 H002770 9/30/2022 68180-217-09 H003194 11/30/2022 68180-217-09 H003195 11/30/2022 68180-217-09 H100009 12/31/2022 68180-217-09 H100010 12/31/2022 68180-217-09 H100021 12/31/2022 68180-217-09 H100022 12/31/2022 68180-217-09 H100023 12/31/2022 68180-217-09 H100029 12/31/2022 68180-217-09 H100030 12/31/2022 68180-217-09 H100342 1/31/2023 68180-217-09 H100343 1/31/2023 68180-217-09 H100344 1/31/2023 68180-217-09 H100345 1/31/2023 68180-217-09 H100346 1/31/2023 68180-217-09 H100374 1/31/2023 68180-217-09 H100375 1/31/2023 68180-217-09 H100376 1/31/2023 68180-217-09 H100377 1/31/2023 68180-217-09 H100378 1/31/2023 68180-217-09 H100452 1/31/2023 68180-217-09 H100453 1/31/2023 68180-217-09 H100454 2/28/2023 68180-217-09 H100458 2/28/2023 68180-217-09 H100459 2/28/2023 68180-217-09 H100652 2/28/2023 68180-217-09 H100653 2/28/2023 68180-217-09 H100654 2/28/2023 68180-217-09 H100655 2/28/2023 68180-217-09 H100656 2/28/2023 68180-217-09 H100687 2/28/2023 68180-217-09 H100688 2/28/2023 68180-217-09 H100689 2/28/2023 68180-217-09 H100703 2/28/2023 68180-217-09 H100704 2/28/2023 68180-217-09 H100891 3/31/2023 68180-217-09 H100892 3/31/2023 68180-217-09 H100902 3/31/2023 68180-217-09 H100903 3/31/2023 68180-217-09 H100904 3/31/2023 68180-217-09 H100905 3/31/2023 68180-217-09 H100936 3/31/2023 68180-217-09 H100937 3/31/2023 68180-217-09 H100938 3/31/2023 68180-217-09 H101153 5/31/2023 68180-217-09 H101154 5/31/2023 68180-217-09 H101155 5/31/2023 68180-217-09 H101156 5/31/2023 68180-217-09 H101157 5/31/2023 68180-217-09 H101158 5/31/2023 68180-217-09 H101159 5/31/2023 68180-217-09 H101294 5/31/2023 68180-217-09 H101295 5/31/2023 68180-217-09 H101296 5/31/2023 68180-217-09 H101297 5/31/2023 68180-217-09 H101325 5/31/2023 68180-217-09 H101326 6/30/2023 68180-217-09 H101327 6/30/2023 68180-217-09 H101328 6/30/2023 68180-217-09 H101349 6/30/2023 68180-217-09 H101350 6/30/2023 68180-217-09 H101351 6/30/2023 68180-217-09 H101352 6/30/2023 68180-217-09 H101482 6/30/2023 68180-217-09 H101483 6/30/2023 68180-217-09 H101606 7/31/2023 68180-217-09 H101618 7/31/2023 68180-217-09 H101619 7/31/2023 68180-217-09 H101620 7/31/2023 68180-217-09 H101621 7/31/2023 68180-217-09 H101827 7/31/2023 68180-217-09 H101828 7/31/2023 68180-217-09 H101829 7/31/2023 68180-217-09 H101857 7/31/2023 68180-217-09 H101858 7/31/2023 68180-217-09 H101911 7/31/2023 68180-217-09 H101912 7/31/2023 68180-217-09 H101913 7/31/2023 68180-217-09 H102455 10/31/2023 68180-217-09 H102456 10/31/2023 68180-217-09 H102457 10/31/2023 68180-217-09 H102458 10/31/2023 68180-217-09 H102485 10/31/2023 68180-217-09 H102489 10/31/2023 68180-217-09 H102490 10/31/2023 68180-217-09 H102491 10/31/2023 68180-217-09
- Postal code
- 21202-6174
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0842-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 303,696 bottles
- Termination date
- May 22, 2023
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Mar 31, 2022
- Initial firm notification
- Letter
- Center classification date
- May 3, 2022