During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
The product was found to contain undeclared sulfites (1329.2 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.