Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Code information: Lot #: a) 092415-1, Exp. 05/21/2018; b) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018; c) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018 d) 092415-1, Exp. 05/21/2018;

Distribution pattern: Nationwide within USA.