Prescription and over-the-counter medications
Bristol-Myers Squibb Company
Lack of Assurance of Sterility.
Failed Dissolution Specifications
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Discoloration
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Dissolution Specifications
Amerisource Health Services
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
ASTRAZENECA PHARMACEUTICALS
Lack of Assurance of Sterility:
IntegraDose Compounding Services
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Failed Dissolution Specifications
Failed Dissolution Specifications
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
SV Labs Prescott
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Failed Content Uniformity Specifications
The Harvard Drug Group LLC
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The Harvard Drug Group LLC
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit