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Showing 4001–4020 of 14370 results

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Metformin Tablets (Preferred) – NDMA Contamination (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDANov 1, 2020FL, IN• Preferred Pharmaceuticals, Inc.

Mesalamine Tablets (AVKARE) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDAOct 30, 2020Nationwide• AVKARE Inc.

Chlorhexidine Oral Rinse (Lohxa) – Microbial Contamination (2020)

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Class IHigh

FDAOct 28, 2020FL, IN, NY• Lohxa LLC

Mesalamine Tablets (Teva) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Class IIModerate

FDAOct 28, 2020Nationwide• Teva Pharmaceuticals USA

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

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

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Class IHigh

FDAOct 27, 2020Nationwide• Sunstar Americas, Inc.

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Olanzapine ODT (Jubilant) – Subpotent Medication (2020)

Subpotent

Class IIILow

FDAOct 26, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Hydrocodone-Acetaminophen (Ascent) – Foreign Tablet (2020)

Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.

Class IIModerate

FDAOct 26, 2020Nationwide• Ascent Pharmaceuticals, Inc.

Metformin HCL Extended-Release 750mg (Nostrum) – NDMA Impurity (2020)

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

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Felodipine Extended Release 10mg (Heritage) – Impurity Specifications (2020)

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

Class IIILow

FDAOct 23, 2020Nationwide• Heritage Pharmaceuticals Inc

Metformin HCL Extended-Release 500mg (Nostrum) – NDMA Impurity (2020)

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

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Children's Ibuprofen Suspension (Aurobindo) – Missing Dosing Cups (2020)

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

Class IIILow

FDAOct 22, 2020NJ• Aurobindo Pharma USA Inc.

Vapor Ointment (H & H Remedies) – Manufacturing Deviation (2020)

CGMP Deviations

Class IIModerate

FDAOct 21, 2020Nationwide• H & H Remedies, LLC

Metformin HCL Extended-Release 750mg (RemedyRepack) – NDMA Impurity (2020)

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

Class IIModerate

FDAOct 11, 2020IN, PA• RemedyRepack Inc.

Dextroamphetamine Mixture (ANI) – Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

N-A-C 500mg Capsules (Jarrow) – Mislabeling Issue (2020)

Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.

Class IIModerate

FDAOct 9, 2020Nationwide• Jarrow Formulas Inc

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