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Showing 4841–4860 of 14370 results

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Anagrelide Capsules (Torrent) - impurity specification (2019)

Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.

Class IIModerate

FDASep 6, 2019Nationwide• Torrent Pharma Inc.

Bacteriostatic Water (Pfizer) - sterility risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDASep 6, 2019Nationwide• Pfizer Inc.

Nucala (Cardinal Health) - temperature storage issue (2019)

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

Class IIModerate

FDASep 6, 2019Nationwide• Cardinal Health dba Specialty Pharmaceutical Services

Matzim LA Tablets (Teva) - distribution deviation (2019)

GMP Deviation: lot not intended for commercial distribution.

FDASep 6, 2019Nationwide• Teva Pharmaceuticals USA

Gatifloxacin Eye Solution (Mylan) - impurity specification (2019)

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

FDASep 6, 2019Nationwide• Mylan Pharmaceuticals Inc.

Pantoprazole Tablets (Jubilant) - tablet discoloration (2019)

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Class IIModerate

FDASep 4, 2019MS, OH, RI +2 more• Jubilant Cadista Pharmaceuticals, Inc.

Clonidine HCL Combination (Anazao Health) – Fungal Contamination (2019)

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Class IIModerate

FDASep 3, 2019Nationwide• Coast Quality Pharmacy, LLC dba Anazao Health

Sufentanil/Clonidine/Bupivacaine (Anazao Health) – Fungal Contamination (2019)

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Class IIModerate

FDASep 3, 2019Nationwide• Coast Quality Pharmacy, LLC dba Anazao Health

Milk of Magnesia (Plastikon) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

FDAAug 30, 2019Nationwide• Plastikon Healthcare LLC

Bevacizumab 2.5mg Injection (AmEx Pharmacy) – Sterility Concern (2019)

Lack of assurance of sterility.

Class IIModerate

FDAAug 30, 2019PR• Pacifico National, Inc. dba AmEx Pharmacy

Bevacizumab 1.25mg Injection (AmEx Pharmacy) – Sterility Concern (2019)

Lack of assurance of sterility.

Class IIModerate

FDAAug 30, 2019PR• Pacifico National, Inc. dba AmEx Pharmacy

Losartan Potassium Prescription Bottles (Sandoz) – Quality Issue (2019)

This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers. The recalled bottles have "Sandoz," the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels. The recall includes the following: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Ezetimibe 10mg Tablets 0781-5690-31 JE4491 Aug-2020 30 count bottle JE4492 Aug-2020 JE4493 Aug-2020 JE4495 Aug-2020 JG0308 Sep-2020 JG0310 Sep-2020 JG0311 Sep-2020 JG0312 Sep-2020 JG5061 Sep-2020 JG5063 Sep-2020 JK8921 Oct-2020 JK8922 Oct-2020 JK8923 Oct-2020 JK8924 Oct-2020 JL5535 Oct-2020 JM2253 Oct-2020 JM2254 Oct-2020 JM2255 Oct-2020 JM2257 Oct-2020 JM2258 Oct-2020 JM2259 Oct-2020 JM5986 Oct-2020 JM5987 Oct-2020 Ezetimibe 10mg Tablets 0781-5690-92 JE4481 Aug-2020 90 count bottle JG0249 Sep-2020 JK8989 Oct-2020 JN0764 Jan-2021 Losartan Potassium 50mg Tablets 0781-5701-31 HV9471 Feb-2020 30 count bottle

CPSCAug 29, 2019Nationwide

Cisplatin API (Johnson Matthey) – Glass Contamination (2019)

cGMP Deviations: Potential glass contamination

Class IIModerate

FDAAug 29, 2019Nationwide• Johnson Matthey Inc.

Fexofenadine Tablets (Preferred Pharmaceuticals) – Impurity Failure (2019)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAAug 29, 2019FL, IN• Preferred Pharmaceuticals, Inc

Fentanyl Citrate API (Johnson Matthey) – Glass Contamination (2019)

cGMP Deviations: Potential glass contamination

Class IIModerate

FDAAug 29, 2019Nationwide• Johnson Matthey Inc.

Oxaliplatin API (Johnson Matthey) – Glass Contamination (2019)

cGMP Deviations: Potential glass contamination

Class IIModerate

FDAAug 29, 2019Nationwide• Johnson Matthey Inc.

Ascorbic Acid Injection (Atlas Pharmaceuticals) – Mislabeling (2019)

Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.

Class IIModerate

FDAAug 28, 2019AZ, CO, IN• Atlas Pharmaceuticals, LLC

Ancient Youth Secret Bottles (Jivan Shakti) – Vitamin Mislabeling (2019)

Product label declares Vitamin D3 at 200 IU per serving. FDA sample analysis revealed no Vitamin D in product.

FDAAug 28, 2019AZ, CA, CT +17 more• Jivan Shakti Inc.

Minolira Tablets (EPI Health) – Dissolution Failure (2019)

Failed Dissolution Specifications:

FDAAug 26, 2019Nationwide• EPI Health, LLC

RAD-140 Capsules (Entropic Labs) – Unapproved Substance (2019)

Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)

Class IIModerate

FDAAug 24, 2019Nationwide• Tuscano and Delucia Group (DBA Entropic Labs)

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