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Showing 4621–4640 of 14370 results

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Ranitidine Oral Solution (Precision Dose) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

Class IIModerate

FDANov 13, 2019Nationwide• Precision Dose Inc.

Fluphenazine Decanoate (AuroMedics) – Solution Discoloration (2019)

Discoloration; Hazy solution found in one vial instead of a clear solution.

Class IIModerate

FDANov 12, 2019Nationwide• AuroMedics Pharma LLC

Fentanyl Bupivacaine Injection (QuVa Pharma) – Glass Particulate Risk (2019)

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIModerate

FDANov 12, 2019Nationwide• QuVa Pharma, Inc.

Lidocaine HCl Injection (AuroMedics) – Foreign Substance Risk (2019)

Presence of Foreign Substance: Foreign material found inside the vial.

Class IIModerate

FDANov 11, 2019Nationwide• AuroMedics Pharma LLC

Amiodarone Hydrochloride Injection (AuroMedics) – Crystallization Risk (2019)

Crystallization: Presence of visible particulate matter.

Class IIILow

FDANov 11, 2019Nationwide• AuroMedics Pharma LLC

Amiodarone Hydrochloride Injection (AuroMedics) – Crystallization Risk (2019)

Crystallization: Presence of visible particulate matter.

Class IIILow

FDANov 11, 2019Nationwide• AuroMedics Pharma LLC

Amiodarone Hydrochloride Injection (AuroMedics) – Crystallization Risk (2019)

Crystallization: Presence of visible particulate matter.

Class IIILow

FDANov 11, 2019Nationwide• AuroMedics Pharma LLC

UP2 Dietary Supplement (Med Man Distribution) – Undeclared Sildenafil (2019)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Class IHigh

FDANov 8, 2019Nationwide• Med Man Distribution, Inc.

Bow & Arrow Supplement (Med Man Distribution) – Undeclared Ingredient (2019)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Class IHigh

FDANov 8, 2019Nationwide• Med Man Distribution, Inc.

Ranitidine Capsules 150mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Syrup (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Capsules 300mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Capsules 150mg (Golden State Medical) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDANov 6, 2019AZ, IA, MA +1 more• Golden State Medical Supply Inc.

Ranitidine Capsules 300mg (Golden State Medical) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDANov 6, 2019AZ, IA, MA +1 more• Golden State Medical Supply Inc.

Ranitidine Capsules 150mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

DG Health Acid Reducer (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Vitamin D2 Blend (Cain Food) – Salmonella Contamination (2019)

Salmonella

Possible contamination with Salmonella

Class IHigh

FDANov 5, 2019AR, IL, KS +4 more• Cain Food Industries, Inc

Valganciclovir Oral Solution (Teva) – Foreign Particles (2019)

Presence of foreign substance: Brown/black particles found during stability testing.

Class IIModerate

FDANov 4, 2019Nationwide• Teva Pharmaceuticals USA, Inc.

Cefdinir Oral Suspension 125mg (Lupin) – Dead Ant Found (2019)

Presence of Foreign substance: identified as a dead ant.

Class IIILow

FDANov 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Hydrocodone Oral Solution (KVK-Tech) – Black Particles (2019)

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Class IIModerate

FDANov 1, 2019Nationwide• KVK-Tech, Inc.

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