Lack of Assurance of Sterility
Drugs Recalls
Prescription and over-the-counter medications
CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
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.
CETUXIMAB 335 MG / 167.5 ML IVPB, 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
CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Infusion Options
Lack of Assurance of Sterility
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
American Health Packaging
Failed Dissolution Specifications
PEMBROLIZUMAB 200 MG / 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
Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
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.
Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0906-30
RXQ Compounding
Lack of Assurance of Sterility
VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0976-30
RXQ Compounding
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0955-30
RXQ Compounding
Lack of Assurance of Sterility
Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Lack of Assurance of Sterility
Lack of Assurance of Sterility