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Showing 4081–4100 of 14370 results

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WP Thyroid Westhroid Pure 1.5 Grain (RLC Labs) – Manufacturing Deviation (2020)

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Class IIModerate

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature Throid 1.25 Grain (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature Throid 1.5 Grain (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

Class IHigh

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature-Throid Thyroid USP (RLC Labs) – Manufacturing Deviation (2020)

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Class IIModerate

FDAAug 25, 2020Nationwide• RLC Labs Inc.

WP Thyroid Westhroid Pure 1/2 Grain (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature Throid 2 Grain (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature Throid 1/2 Grain (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature Throid Thyroid USP (RLC Labs) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found product to be subpotent

FDAAug 25, 2020Nationwide• RLC Labs Inc.

WP Thyroid Westhroid Pure 1 Grain (RLC Labs) – Manufacturing Deviation (2020)

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Class IIModerate

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature-Throid Thyroid USP (RLC Labs) – Manufacturing Deviation (2020)

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Class IIModerate

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Nature-Throid Thyroid USP (RLC Labs) – Manufacturing Deviation (2020)

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Class IIModerate

FDAAug 25, 2020Nationwide• RLC Labs Inc.

Cephalexin Oral Suspension 250mg (Teva) – Potency Inconsistency (2020)

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Potassium Chloride Tablets (Strides) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDAAug 24, 2020Nationwide• Strides Inc.

Cephalexin Oral Suspension 125mg (Teva) – Potency Inconsistency (2020)

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Cephalexin Oral Suspension 250mg (Teva) – Medication Potency (2020)

Sub-Potent Drug: Out of specification test results for potency (below specification).

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Metformin Extended-Release 750mg (Bayshore) – Manufacturing Issues (2020)

CGMP Deviations

Class IIModerate

FDAAug 19, 2020Nationwide• BAYSHORE PHARMACEUTICALS

Metformin Extended-Release 500mg (Bayshore) – Manufacturing Issues (2020)

CGMP Deviations

Class IIModerate

FDAAug 19, 2020Nationwide• BAYSHORE PHARMACEUTICALS

Tranexamic Acid Injection (Mylan) – Labeling Mix-Up (2020)

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

FDAAug 17, 2020Nationwide• Mylan Institutional LLC

Amiodarone HCl Injection (Mylan) – Labeling Mix-Up (2020)

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

FDAAug 17, 2020Nationwide• Mylan Institutional LLC

Buprenorphine HCl Injection (Hikma) – Potency Deviation (2020)

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

Class IIModerate

FDAAug 14, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

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