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Macleods Pharma Usa Inc

Macleods Pharma Usa Inc Recalls

All product recalls associated with Macleods Pharma Usa Inc.

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Recall Summary

Total Recalls

33

Past Year

0

Class I (Serious)

0

Most Recent

May 2024

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 21–33 of 33 recalls

Pioglitazone Tablets (Macleods) – potency problem (2019)

Superpotent

Class IIModerate

FDASep 23, 2019Nationwide• Macleods Pharma Usa Inc

Pramipexole Tablets (Macleods) – Subpotent Drug Stability (2019)

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

FDAAug 21, 2019Nationwide• Macleods Pharma Usa Inc

Tamsulosin Hydrochloride Capsules (Macleods) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

12

Page 2 of 2Next

FDA

Jul 17, 2019

Nationwide

• Macleods Pharma Usa Inc

Losartan-Hydrochlorothiazide 100/12.5mg (Macleods) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 20, 2019Nationwide• Macleods Pharma Usa Inc

Losartan-Hydrochlorothiazide 100/25mg (Macleods) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 20, 2019Nationwide• Macleods Pharma Usa Inc

Losartan Potassium Tablets 50mg (Macleods) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 20, 2019Nationwide• Macleods Pharma Usa Inc

Losartan Potassium Tablets 50mg (Macleods) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 20, 2019Nationwide• Macleods Pharma Usa Inc

Losartan-Hydrochlorothiazide 50/12.5mg (Macleods) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 20, 2019Nationwide• Macleods Pharma Usa Inc

Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class IIModerate

FDAFeb 25, 2019Nationwide• Macleods Pharma Usa Inc

Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class IIModerate

FDAFeb 25, 2019Nationwide• Macleods Pharma Usa Inc

Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class IIModerate

FDAFeb 25, 2019Nationwide• Macleods Pharma Usa Inc

Losartan Potassium Tablets (Macleods) – NDEA Contamination (2019)

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Class IIModerate

FDAFeb 21, 2019FL, NJ, NY• Macleods Pharma Usa Inc

Pramipexole Dihydrochloride Tablets (Macleods) – Foreign Tablet Presence (2015)

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Class IIModerate

FDADec 24, 2015Nationwide• Macleods Pharma Usa Inc