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/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot numbers, UPCs & expiration codes
Lot # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-09 H001795 6/30/2022 68180-216-09 H001796 6/30/2022 68180-216-09 H001797 6/30/2022 68180-216-09 H001879 6/30/2022 68180-216-09 H001880 6/30/2022 68180-216-09 H001881 6/30/2022 68180-216-09 H001942 6/30/2022 68180-216-09 H001943 6/30/2022 68180-216-09 H001944 6/30/2022 68180-216-09 H001945 6/30/2022 68180-216-09 H001946 6/30/2022 68180-216-09 H002179 7/31/2022 68180-216-09 H002180 7/31/2022 68180-216-09 H002181 8/31/2022 68180-216-09 H002182 8/31/2022 68180-216-09 H002183 8/31/2022 68180-216-09 H002237 8/31/2022 68180-216-09 H002238 8/31/2022 68180-216-09 H002239 8/31/2022 68180-216-09 H002240 8/31/2022 68180-216-09 H002241 8/31/2022 68180-216-09 H002627 9/30/2022 68180-216-09 H002628 9/30/2022 68180-216-09 H002629 9/30/2022 68180-216-09 H002630 9/30/2022 68180-216-09 H002631 9/30/2022 68180-216-09 H002979 11/30/2022 68180-216-09 H002980 11/30/2022 68180-216-09 H002981 11/30/2022 68180-216-09 H002982 11/30/2022 68180-216-09 H002983 11/30/2022 68180-216-09 H100112 12/31/2022 68180-216-09 H100113 12/31/2022 68180-216-09 H100114 12/31/2022 68180-216-09 H100115 12/31/2022 68180-216-09 H100116 12/31/2022 68180-216-09 H100156 12/31/2022 68180-216-09 H100157 12/31/2022 68180-216-09 H100622 2/28/2023 68180-216-09 H100623 2/28/2023 68180-216-09 H100624 2/28/2023 68180-216-09 H100625 2/28/2023 68180-216-09 H100626 2/28/2023 68180-216-09 H100627 2/28/2023 68180-216-09 H100628 2/28/2023 68180-216-09 H100629 2/28/2023 68180-216-09 H100939 4/30/2023 68180-216-09 H100940 4/30/2023 68180-216-09 H100941 4/30/2023 68180-216-09 H100942 4/30/2023 68180-216-09 H100943 4/30/2023 68180-216-09 H101094 5/31/2023 68180-216-09 H101095 5/31/2023 68180-216-09 H101096 5/31/2023 68180-216-09 H101097 5/31/2023 68180-216-09 H101098 5/31/2023 68180-216-09 H101151 5/31/2023 68180-216-09 H101152 5/31/2023 68180-216-09 H101290 5/31/2023 68180-216-09 H101291 5/31/2023 68180-216-09 H101292 5/31/2023 68180-216-09 H101293 5/31/2023 68180-216-09 H101323 5/31/2023 68180-216-09 H101324 5/31/2023 68180-216-09 H101823 7/31/2023 68180-216-09 H101824 7/31/2023 68180-216-09 H101825 7/31/2023 68180-216-09 H101853 8/31/2023 68180-216-09 H101854 8/31/2023 68180-216-09 H101855 8/31/2023 68180-216-09 H101856 8/31/2023 68180-216-09 H102127 9/30/2023 68180-216-09 H102128 9/30/2023 68180-216-09 H102129 9/30/2023 68180-216-09 H102130 9/30/2023 68180-216-09 H102150 9/30/2023 68180-216-09 H102151 9/30/2023 68180-216-09 H102152 9/30/2023 68180-216-09 H102153 9/30/2023 68180-216-09 H102154 9/30/2023 68180-216-09 H102155 9/30/2023 68180-216-09 H102201 9/30/2023 68180-216-09 H102223 9/30/2023 68180-216-09 H102268 9/30/2023 68180-216-09 H102269 9/30/2023 68180-216-09 H102270 9/30/2023 68180-216-09 H102271 9/30/2023 68180-216-09
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-0843-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2022
- FDA report date
- May 11, 2022
- Quantity
- 2,361,924 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0843-2022, 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 # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-09 H001795 6/30/2022 68180-216-09 H001796 6/30/2022 68180-216-09 H001797 6/30/2022 68180-216-09 H001879 6/30/2022 68180-216-09 H001880 6/30/2022 68180-216-09 H001881 6/30/2022 68180-216-09 H001942 6/30/2022 68180-216-09 H001943 6/30/2022 68180-216-09 H001944 6/30/2022 68180-216-09 H001945 6/30/2022 68180-216-09 H001946 6/30/2022 68180-216-09 H002179 7/31/2022 68180-216-09 H002180 7/31/2022 68180-216-09 H002181 8/31/2022 68180-216-09 H002182 8/31/2022 68180-216-09 H002183 8/31/2022 68180-216-09 H002237 8/31/2022 68180-216-09 H002238 8/31/2022 68180-216-09 H002239 8/31/2022 68180-216-09 H002240 8/31/2022 68180-216-09 H002241 8/31/2022 68180-216-09 H002627 9/30/2022 68180-216-09 H002628 9/30/2022 68180-216-09 H002629 9/30/2022 68180-216-09 H002630 9/30/2022 68180-216-09 H002631 9/30/2022 68180-216-09 H002979 11/30/2022 68180-216-09 H002980 11/30/2022 68180-216-09 H002981 11/30/2022 68180-216-09 H002982 11/30/2022 68180-216-09 H002983 11/30/2022 68180-216-09 H100112 12/31/2022 68180-216-09 H100113 12/31/2022 68180-216-09 H100114 12/31/2022 68180-216-09 H100115 12/31/2022 68180-216-09 H100116 12/31/2022 68180-216-09 H100156 12/31/2022 68180-216-09 H100157 12/31/2022 68180-216-09 H100622 2/28/2023 68180-216-09 H100623 2/28/2023 68180-216-09 H100624 2/28/2023 68180-216-09 H100625 2/28/2023 68180-216-09 H100626 2/28/2023 68180-216-09 H100627 2/28/2023 68180-216-09 H100628 2/28/2023 68180-216-09 H100629 2/28/2023 68180-216-09 H100939 4/30/2023 68180-216-09 H100940 4/30/2023 68180-216-09 H100941 4/30/2023 68180-216-09 H100942 4/30/2023 68180-216-09 H100943 4/30/2023 68180-216-09 H101094 5/31/2023 68180-216-09 H101095 5/31/2023 68180-216-09 H101096 5/31/2023 68180-216-09 H101097 5/31/2023 68180-216-09 H101098 5/31/2023 68180-216-09 H101151 5/31/2023 68180-216-09 H101152 5/31/2023 68180-216-09 H101290 5/31/2023 68180-216-09 H101291 5/31/2023 68180-216-09 H101292 5/31/2023 68180-216-09 H101293 5/31/2023 68180-216-09 H101323 5/31/2023 68180-216-09 H101324 5/31/2023 68180-216-09 H101823 7/31/2023 68180-216-09 H101824 7/31/2023 68180-216-09 H101825 7/31/2023 68180-216-09 H101853 8/31/2023 68180-216-09 H101854 8/31/2023 68180-216-09 H101855 8/31/2023 68180-216-09 H101856 8/31/2023 68180-216-09 H102127 9/30/2023 68180-216-09 H102128 9/30/2023 68180-216-09 H102129 9/30/2023 68180-216-09 H102130 9/30/2023 68180-216-09 H102150 9/30/2023 68180-216-09 H102151 9/30/2023 68180-216-09 H102152 9/30/2023 68180-216-09 H102153 9/30/2023 68180-216-09 H102154 9/30/2023 68180-216-09 H102155 9/30/2023 68180-216-09 H102201 9/30/2023 68180-216-09 H102223 9/30/2023 68180-216-09 H102268 9/30/2023 68180-216-09 H102269 9/30/2023 68180-216-09 H102270 9/30/2023 68180-216-09 H102271 9/30/2023 68180-216-09
- Postal code
- 21202-6174
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0843-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 2,361,924 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/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), 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