Prescription and over-the-counter medications
Acella Pharmaceuticals
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Out-of-specification organic impurity results obtained during routine stability testing.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Genesis Partnership Company SA
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Genesis Partnership Company SA
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Genesis Partnership Company SA
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Genesis Partnership Company SA
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Calvin Scott & Company
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Calvin Scott & Company
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
CGMP Deviations: Presence of NDMA impurity detected in product.
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Calvin Scott & Company
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
PAI Holdings, LLC.
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
CGMP Deviations: Presence of NDMA impurity detected in product.
Failed Stability Specifications: Below specification result for buprenorphine release rate.