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Showing 4321–4340 of 14370 results

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Lycopene Supplement (CT Health Solutions) – Low Potency (2020)

Due to different color of powder in capsules. Firm's evaluation determined product low potency.

FDAMar 27, 2020IN, MI• CT Health Solutions, LLC

Testosterone Cypionate (Innovative) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 26, 2020CA, IN, ME +1 more• Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

MIC-8 Injectable (Innovative) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 26, 2020CA, IN, ME +1 more• Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Losartan Potassium 100mg (Avet) – CGMP Impurity Detection (2020)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

Class IIModerate

FDAMar 26, 2020Nationwide• Avet Pharmaceuticals, Inc.

Losartan Potassium 50mg (Avet) – CGMP Impurity Detection (2020)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

Class IIModerate

FDAMar 26, 2020Nationwide• Avet Pharmaceuticals, Inc.

Methylcobalamin Solution (Innovative) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 26, 2020CA, IN, ME +1 more• Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Alprostadil Injectable (Innovative) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 26, 2020CA, IN, ME +1 more• Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Hydroxyprogesterone Caproate (Innovative) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 26, 2020CA, IN, ME +1 more• Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Fentanyl Citrate Injection (Akorn) – Impurity Specification Failure (2020)

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

FDAMar 25, 2020Nationwide• Akorn Inc

Losartan Potassium 25mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Losartan Potassium 50mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Losartan Potassium 100mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Detoxin-S (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Pain Stopper Capsules (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Acne Cystic Capsules (Herbal Doctor) – CGMP Misbranding (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Reman-8 (Herbal Doctor Remedies) – Misbranded Drugs (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Dermatoxin (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Thyro-Lo (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Voice Rescue (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

Fire Off (Herbal Doctor Remedies) – Unapproved Drug (2020)

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Class IIModerate

FDAMar 24, 2020Nationwide• Herbal Doctor Remedies

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