Lupin Pharmaceuticals Inc.: 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

Is my product affected?

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

• Brand LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Check against the official notice below — it lists the full affected range.

What happened

Lupin Pharmaceuticals Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg in both 30-count and 90-count bottles due to CGMP deviations involving azido impurity levels that exceeded acceptable limits. A total of 303,696 bottles were distributed nationwide, with affected lot numbers and expiration dates ranging from April 2022 through July 2023.

The recall record does not specify a remedy or recommended action for consumers who have obtained this medication.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Details from the source

Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Distribution: Product was distributed nationwide Quantity: 303,696 bottles Lot/code info: 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 H00263

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-03-31
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