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Showing 2821–2840 of 14370 results

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Testosterone Cypionate/Anastrozole Oil (Drug Depot) – Sterility Concern (2022)

Lack of sterility assurance.

Class IIModerate

FDAMar 23, 2022Nationwide• Drug Depot, Inc., dba APS Pharmacy

Quinapril/Hydrochlorothiazide Tablets (Pfizer) – Impurity Limit Exceeded (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Symjepi Epinephrine Injection (Adamis) – Delivery System Defect (2022)

Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.

Class IHigh

FDAMar 21, 2022Nationwide• Adamis Pharmaceuticals Corporation

Accuretic Tablets (Pfizer) – CGMP Impurity Risk (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Accuretic Tablets (Pfizer) – CGMP Impurity Risk (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Accuretic Tablets (Pfizer) – CGMP Impurity Risk (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Quinapril-Hydrochlorothiazide Tablets (Pfizer) – CGMP Impurity Risk (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Orphenadrine Tablets (Sandoz) – Nitrosamine Impurity (2022)

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Sandoz, Inc

SYMJEPI Epinephrine Injection (Adamis) – Potential Needle Clogging (2022)

Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.

FDAMar 21, 2022Nationwide• Adamis Pharmaceuticals Corporation

Accuretic Tablets 20mg (Pfizer) – Impurity Limit Exceeded (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Accuretic Tablets 10mg (Pfizer) – Impurity Limit Exceeded (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

Quinapril-Hydrochlorothiazide Tablets (Pfizer) – CGMP Impurity Risk (2022)

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Class IIModerate

FDAMar 21, 2022Nationwide• Pfizer Inc.

NETSPOT Dotatate Kit (Advanced Accelerator) – Subpotent Drug (2022)

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

FDAMar 18, 2022Nationwide• Advanced Accelerator Applications USA, Inc.

PhysiciansCare OTC Drugs (Acme United) – Quality Compliance (2022)

This recall involves the PhysiciansCare brand Extra Strength Non Aspirin, Aspirin, Extra Strength Pain Reliever, Ibuprofen, Medication Station, and Multi-Pack over-the-counter drugs. The products contain aspirin, acetaminophen, or ibuprofen. They are packaged in cardboard boxes of 50, 100, 250, and 500 tablets per box. Product Drug Tablet Amount Extra Strength Non Aspirin Acetaminophen (500 mg) 50 tablets 100 tablets 250 tablets 500 tablets 2 boxes of 100 tablets each Aspirin Aspirin (325 mg) 50 tablets 100 tablets 250 tablets 500 tablets Extra Strength Pain Reliever Acetaminophen (250 mg) Aspirin (250 mg) 100 tablets 250 tablets Ibuprofen Ibuprofen (200 mg) 100 tablets 250 tablets 500 tablets 2 boxes of 100 tablets each Medication Station / Multi-Pack Acetaminophen (500 mg) Aspirin (325 mg) Ibuprofen (200 mg) Antacid (420 mg) 4 boxes of 100 tablets each with outer station 4 boxes of 100 tablets each without outer station The Antacid is not subject to this recall.

CPSCMar 17, 2022Nationwide• Acme United of Rocky Mount, North Carolina

Glycopyrrolate Tablets (Aurolife) – Glass Contamination (2022)

Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

Class IIModerate

FDAMar 17, 2022Nationwide• Aurolife Pharma, LLC

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

CGMP Deviations

Class IIModerate

FDAMar 16, 2022Nationwide• Golden State Medical Supply Inc.

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

CGMP Deviations

Class IIModerate

FDAMar 16, 2022Nationwide• Golden State Medical Supply Inc.

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

FDAMar 16, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

CGMP Deviations

Class IIModerate

FDAMar 16, 2022Nationwide• Golden State Medical Supply Inc.

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

CGMP Deviations

Class IIModerate

FDAMar 16, 2022Nationwide• Golden State Medical Supply Inc.

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