All Recalls

The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.

Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.

Undeclared allergens of egg and milk due to incorrect label

A small amount of product that was on hold due to potential for metal contamination was released into distribution.

Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.

Undeclared milk

Undeclared Wheat, Sesame and Soybean oil.

Undeclared milk.

Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.

FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.

FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.

Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.

FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firm's sprouts with an outbreak of E. coli.

Private brand customer received 3 complaints of consumers finding the incorrect master pack (kit with dressing and other toppings) in 12.6 oz. Tuscan Herb Chopped Kit. The dressing included was Sweet Thai which contains peanuts, tree nuts and wheat that were not declared on label.

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.