Macleods Pharma Usa Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count recall — FDA D-1005-2019
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Microbial contamination
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the…
Microbial contamination
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Microbial contamination
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time…
Microbial contamination
Microbial contamination
Microbial contamination
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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