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Showing 4861–4880 of 14370 results

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Pramipexole Tablets (Macleods) – Subpotent Drug Stability (2019)

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

FDAAug 21, 2019Nationwide• Macleods Pharma Usa Inc

Ketamine Injection (SCA) – Sterility Concern (2019)

Lack of Assurance of Sterility.

Class IIModerate

FDAAug 16, 2019Nationwide• SCA Pharmaceuticals, LLC

Relpax Tablets (Pfizer) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

Class IIModerate

FDAAug 14, 2019Nationwide• Pfizer Inc.

S-Dextrose/Glycerin/Phenol Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Estradiol Cyp 5mg/ml (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Edetate Calcium 300mg/ML Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Cyanocobalamin 1,000 MCG/ML Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Atropine Ophthalmic Solution (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-DMPS Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Procaine HCL Solution (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Lidocaine/Phenylephrine Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Trimix Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

S-Folic Acid Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Methylcobalamin Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Phenol Injection Solution (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

MIC Solution (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Dexpanthenol Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Estradiol/Testosterone Injection (Red Mountain) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lidocaine HCL 2% Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Edetate Disodium 15% Injection (Red Mountain) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 12, 2019Nationwide• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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