Prescription and over-the-counter medications
McGuff Compounding Pharmacy Services
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Shandex Personal Care Manufacturing
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
MPRX, Inc.
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Tuscano and Delucia Group (DBA Entropic Labs)
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Mylan Pharmaceuticals
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Hikma Pharmaceuticals USA
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Mylan Pharmaceuticals
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
RemedyRepack
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Advanced Accelerator Applications USA
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
CGMP Deviations: Presence of NDMA impurity detected in product.
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.