Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing control deviations and elevated AZIDO impurity levels above acceptable limits, with no reported illnesses or injuries. This represents a risk-of-harm situation with a pharmaceutical quality issue.
Plain-English summary
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets manufactured by Vivimed Life Sciences Private Limited. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during quality review.
During quality control assessment, AZIDO impurity levels were found to exceed acceptable pharmaceutical limits in affected batches. The company has initiated the nationwide recall to ensure medication safety and manufacturing compliance.
The recall affects approximately 96,966 bottles distributed nationwide. Affected products include NDC 64380-935-05 (90-tablet bottles) and NDC 64380-935-08 (1000-tablet bottles) with multiple lot numbers and expiration dates ranging from May 2022 through January 2023. Detailed lot information is available from FDA and the manufacturer.
Patients taking Losartan Potassium should check their medication against the detailed recall lot list. Those with affected products should contact their healthcare provider or pharmacist immediately to determine next steps regarding their therapy.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Strides Pharma Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
- azido-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 64380-935-05 Lots 7901047B
- 7901048B
- 7901049B & 7901050B
- Exp Date Jul-22
- Lots 7901185A
- 7901186A
- 7901187A & 7901188A
- Exp Date Oct-22
- Lots 7901250A
- 7901251A & 7901252A
- Exp Date Nov-22. 64380-935-08 Lots 7900813B
- 7900814B
- 7900908A
- 7900935A
- 7900936A
- 7900937A
- 7900938A & 7900939B
- Exp Date May-22
- Lots 7901043A
- 7901044A
UPCs (9)
- 0364380933052
- 0364380935056
- 0364380935087
- 0364380935049
- 0364380934042
- 0364380933045
- 0364380934080
- 0364380933083
- 0364380934059
Distribution
Distributed nationwide across the United States.
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