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Showing 4141–4160 of 14370 results

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Phendimetrazine 35mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Thyroid 1 Gr (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL 37.5mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Hydrochlorothiazide 25mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL 15mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL White/Blue Speck Tabs (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phendimetrazine Brown/Clear Capsules (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Hydrochlorothiazide 50mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL GrayYellow Capsules (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL White/Blue Speckled Tablets (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL Yellow Caps (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

VILAMIT MB (Vilvet) – Quality Deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 24, 2020Nationwide• Vilvet Pharmaceuticals Inc.

VILEVEV MB Urinary Antispetic (Vilvet) – Quality Deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 24, 2020Nationwide• Vilvet Pharmaceuticals Inc.

Clobetasol Propionate Cream (Golden State) – Content Uniformity Issue (2020)

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

FDAJul 24, 2020Nationwide• Golden State Medical Supply Inc.

Iron Drops Sampler (Wellements) – undeclared milk (2020)

Undeclared Milk

Product contains undeclared milk

FDAJul 24, 2020Nationwide• Wellements LLC

Iron Drops (Wellements) – Undeclared milk (2020)

Undeclared Milk

Product contains undeclared milk

FDAJul 24, 2020Nationwide• Wellements LLC

Cheddar Bagel (San Francisco Street Bakery) – Undeclared Soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished product label does not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Pesto Bagel (San Francisco Street Bakery) – Undeclared Soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Poppy Seed Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Everything Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

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