774 recalls, newest first
Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated…
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Reason Failed Dissolution Specifications
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Reason Failed Content Uniformity Specifications
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
Reason Failed Viscosity Specifications: Out-of-specification test results for viscosity
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications.
Reason Failed Impurities/Degradation Specifications.
Reason Subpotent Drug
Reason CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Reason Failed Excipient Specifications: high content of ethylene glycol (EG)
Reason Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25…
Reason CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation…
Reason Labeling: Not Elsewhere Classified
Reason Labeling: Not Elsewhere Classified