All Recalls

Lead level was higher than NYSAGM Standard.

Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40

Undeclared milk.

Product may be contaminated with Salmonella.

Undeclared milk.

Undeclared milk.

Hard corn starch lumps were found in the product

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Lack of Assurance of Sterility

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Unapproved design changes to the products outside of the 510(k) clearance.