18 FDA recalls mention Promethazine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Promethazine.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Processing Controls.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room…
Reason Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Reason Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360…
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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