14,450 recalls · Class II, newest first
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Reason Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Reason Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Reason Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Reason Failed Stability Specifications
Reason Defective Delivery System: Out of specification for adhesive transfer.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.