Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC…
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
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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 Dissolution Specifications: Out of specification for dissolution.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Failed Viscosity Specifications: Out-of-specification test results for viscosity
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Failed Dissolution Specifications
Reason Sub-potent Drug: Lower potency than labeled.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications.
Reason Failed Impurities/Degradation Specifications.
Reason Subpotent Drug
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Reason CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Reason Presence of Particulate Matter: Silicone