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Showing 1821–1840 of 2326 results

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PremierZen Extreme 3000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

IMPERIAL GOLD 2000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

Burro en Primavera (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

Guanfacine Tablets (Apotex) - Cross Contamination (2021)

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Class IIModerate

FDAMar 31, 2021Nationwide• Apotex Corp.

Triple SupremeZen Gold (Na Na) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 30, 2021Nationwide• Na Na Collection

PremierZen Platinum 5000 (Na Na) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 30, 2021Nationwide• Na Na Collection

Imperial Extreme 2000 Capsules (S & B Story) – Unapproved Drug Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Class IIModerate

FDAMar 25, 2021Nationwide• S & B Story LLC

China-Gel (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

Aulief Pain Relief (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

China-Gel White (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

Chocolate-Covered Hunks Sour Goldenberries (Hu) – Undeclared Almonds (2021)

Undeclared Allergen

Product may contain undeclared almonds.

Class IIModerate

FDAMar 5, 2021IL, IA, MD +5 more• HU PRODUCTS

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

Class IIModerate

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Class IIModerate

FDAJan 25, 2021Nationwide• Nostrum Laboratories Inc

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJan 4, 2021Nationwide• Nostrum Laboratories Inc

Paroex Oral Rinse (Sunstar) – Manufacturing Contamination (2020)

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Class IIModerate

FDADec 28, 2020Nationwide• Sunstar Americas, Inc.

Pristine Hand Sanitizer Gel (GAZA) – cGMP Deviation (2020)

cGMP deviations: Product made at the same facility where product tested was sub-potent.

Class IIModerate

FDADec 1, 2020TX• GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

Zapien Hand Sanitizer Gel (GAZA) – cGMP Deviation (2020)

cGMP deviations: Product made at the same facility where product tested was sub-potent.

Class IIModerate

FDADec 1, 2020TX• GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

B12 for Injection (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

FGL (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

CJC-1295 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

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