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
Reported: May 11, 2022 Initiated: March 31, 2022 #D-0842-2022
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
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 303,696 bottles
- Distribution
- Product was distributed nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 303,696 bottles.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0842-2022.
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