135 FDA recalls mention Chlorothiazide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorothiazide.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason Subpotent Drug
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Reason Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002…
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Reason Presence of Particulate Matter
Reason Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Reason Presence of Particulate Matter.
Reason Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Reason Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Reason Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Reason Subpotent; Hydrochlorothiazide at the 9 month time point.
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