Safecor Health

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

Defective Container: Confirmed customer complaints of leaking bottles.

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.