Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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.
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.
Subpotent Drug
Subpotent Drug
Subpotent Drug
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.
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.
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.
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.
Failed Stability Specifications
Defective Delivery System: Out of specification for adhesive transfer.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Processing Controls.