Prescription and over-the-counter medications
Acella Pharmaceuticals
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Acuity Specialty Products
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
The Harvard Drug Group LLC
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Lack of Assurance of Sterility
The Harvard Drug Group LLC
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Lack of assurance of sterility.
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Zydus Pharmaceuticals (USA)
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Zydus Pharmaceuticals (USA)
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Amerisource Health Services
Failed Dissolution Specifications.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Market complaints received for gritty texture (grainy)
Private Label Skin Care
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Consumer Product Partners
Cross Contamination with Other Products.
Consumer Product Partners
Cross Contamination with Other Products.
Private Label Skin Care
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications: