Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
73 FDA recalls mention Triamcinolone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Triamcinolone.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Reason Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Processing Controls
Reason Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability…
Reason Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability…
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Reason CGMP Deviations
Reason Failed Stability Specifications: Low Out of Specification results for alcohol content.
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Processing Controls
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
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