Overview of recall records associated with Heritage Pharmaceuticals, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 16, Class I: 2, Class III: 1.
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
This page summarizes recall records in which the official source identifies Heritage Pharmaceuticals, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
