Sertraline Tablets, USP 100 mg, 30 tablets per bottle recall — FDA D-0205-2024
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Overview of recall records associated with Legacy Pharmaceutical Packaging LLC, including dates, categories and classifications where available.
Classification mix: Class II: 8, Class III: 1.
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
This page summarizes recall records in which the official source identifies Legacy Pharmaceutical Packaging LLC 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.