CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
All Recalls
95,038 total recalls in our database
Lack of Assurance of Sterility
METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
US Pharmaceuticals
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Lack of Assurance of Sterility
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.