162 FDA recalls mention Star. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Star.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning…
Reason Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Reason Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Reason cGMP Deviation
Reason Cross Contamination with Other Products
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Reason Microbial Contamination of Non-Sterile Product
Reason Microbial Contamination of Non-Sterile Products
Reason Microbial Contamination of Non-Sterile Products
Reason Microbial Contamination of Non-Sterile Products
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Reason Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Reason Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Reason Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Reason CGMP Deviations
Reason Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been…
Reason Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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