ICU Medical and Apace Packaging Recall Products – APhA submits compounding comments to FDA. – (866) 348-2889
ICU Medical, Inc, is voluntarily recalling one lot of 0.9% sodium chloride injection, USP 1000 mL, to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. The recall affects National Drug Code (NDC) 0409-7983-09 and lot number 61-841-FW, which expires January 1, 2018. As noted in a safety alert posted to FDA’s website, the affected product was manufactured in the US by Hospira, a Pfizer company, on February 1, 2016, and was distributed nationwide to Hospira customers between April 14, 2016, and February 2, 2017.
Apace Packaging, LLC, is voluntarily recalling one lot of cyclobenzaprine HCl tablet, USP 5 mg, 50-count unit dose (NDC 50268-190-15 and lot number 16710), and one lot of amantadine HCl capsule, USP 100 mg, 50-count unit dose (NDC 50268-069-15 and lot number 16710) to the retail level. These products have been recalled due to potential mislabeling. A small number of cartons containing cyclobenzaprine HCl tablets, 5 mg unit dose blister cards, may potentially be mislabeled as amantadine HCl capsules, USP 100 mg.