Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by…
Reason Failed Impurity/Degradation Specifications
Is Triamterene recalled?
8 FDA recalls mention Triamterene. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Triamterene.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett…
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc…
Reason Subpotent Drug
Class III · Low risk Terminated
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals…
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc…
Reason Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class II · Moderate risk Terminated
TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591042401.
Reason Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: SEVELAMER…
Class II · Moderate risk Terminated
TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378135201.
Reason Labeling: Label Mixup: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg…
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