Legacy Pharmaceutical Packaging LLC Recalls

All product recalls associated with Legacy Pharmaceutical Packaging LLC.

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

0

Most Recent

Dec 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–10 of 10 recalls

Sertraline Tablets (Legacy) – Product Comingling Risk (2023)

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Class IIModerate

FDADec 11, 2023AR, CA• Legacy Pharmaceutical Packaging LLC

Metformin Hydrochloride Tablets (Legacy Packaging) – Foreign Tablets (2020)

Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

Class IIILow

FDASep 24, 2020AR, GA, IN• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – NMBA Impurity (2019)

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Class II

Moderate

FDAApr 24, 2019AZ, TN• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.

Class IIModerate

FDAMar 1, 2019AZ, IN, TN• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Atenolol Tablets (Legacy Pharmaceutical) - Foreign Tablet Mix-up (2017)

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Class IIModerate

FDAMar 7, 2017Nationwide• Legacy Pharmaceutical Packaging LLC

Amlodipine Besylate Tablets (Walmart) – Label Strength Error (2013)

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.

Class IIModerate

FDAApr 22, 2013Nationwide• Legacy Pharmaceutical Packaging LLC