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Showing 7901–7920 of 15081 results

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Atorvastatin Calcium Tablets 20mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Atorvastatin Calcium Tablets 10mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Ciclopirox Olamine Cream (G & W Laboratories) – Outdated Package Insert (2017)

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

FDAMar 20, 2017Nationwide• G & W Laboratories, Inc.

Atorvastatin Calcium Tablets 80mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Atorvastatin Calcium Tablets 40mg (Mylan) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Class IIModerate

FDAMar 20, 2017Nationwide• Mylan Pharmaceuticals Inc.

Latanoprost Ophthalmic Solution (Akorn) – Sterility Concern (2017)

Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.

Class IIModerate

FDAMar 17, 2017Nationwide• Akorn, Inc.

Kalbitor (Shire) – Glass Particulate Presence (2017)

Presence of Particulate Matter: Glass

Class IIModerate

FDAMar 17, 2017Nationwide• Shire

Fluocinonide Cream (Taro Pharmaceuticals) – Cross Contamination (2017)

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

FDAMar 17, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Fluphenazine Decanoate Injection (Fresenius Kabi) – Subpotent Drug (2017)

Subpotent Drug

FDAMar 16, 2017Nationwide• Fresenius Kabi USA, LLC

Lumigan (Allergan) – Failed Impurities (2017)

Failed Impurities/Degradation Specifications

FDAMar 16, 2017Nationwide• Allergan Sales, LLC

Testosterone Cypionate Injection (Sun Pharmaceutical) – Particulate Matter (2017)

Presence of Particulate Matter

Class IIModerate

FDAMar 15, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Divalproex Sodium Tablets (Zydus) – Failed Dissolution (2017)

Failed Dissolution Specifications; 9 month long term stability

Class IIModerate

FDAMar 15, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Cotellic (Genentech) – Superpotent Tablet (2017)

Superpotent Drug: An oversized tablet was found in a bottle.

Class IIModerate

FDAMar 13, 2017IL, NJ• Genentech Inc.

Sulfamethoxazole Trimethoprim Suspension (Akorn) – Failed Dissolution (2017)

Failed Dissolution Specifications

Class IIModerate

FDAMar 13, 2017Nationwide• Akorn Inc

EpiPen (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

EpiPen Jr. (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

Premark Vitamin Premix (McShare's) – Undeclared Soy (2017)

Product manufactured with an ingredient that contains low levels of soy; soy is not declared on product label.

FDAMar 11, 2017IN, MO, TX• McShare's Inc

Fluconazole Injection (Claris) – Sterility Breach (2017)

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Class IIModerate

FDAMar 10, 2017Nationwide• Claris Lifesciences Inc

Ciprofloxacin Injection (Claris) – Sterility Breach (2017)

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Class IIModerate

FDAMar 10, 2017Nationwide• Claris Lifesciences Inc

Metronidazole Injection (Claris) – Sterility Breach (2017)

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Class IIModerate

FDAMar 10, 2017Nationwide• Claris Lifesciences Inc

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