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Showing 13501–13520 of 14370 results

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Proplete 60-69 KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Excedrin Sinus Headache (Novartis) – impurity found (2013)

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

FDAMay 15, 2013Nationwide• Novartis Consumer Health

Baxter LL Bag 2% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Theraflu Warming Relief (Novartis) – impurity found (2013)

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

FDAMay 15, 2013Nationwide• Novartis Consumer Health

Comtrex Day/Night Flu Therapy (Novartis) – impurity found (2013)

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

FDAMay 15, 2013Nationwide• Novartis Consumer Health

Proplete 40-44 KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Comtrex Day/Night Cold & Cough (Novartis) – degradation issue (2013)

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

FDAMay 15, 2013Nationwide• Novartis Consumer Health

Proplete Nutrition (Pentec) – sterility uncertainty (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Proplete 80+ KG (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Baxter LL Bag 1.5% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Baxter Ultrabag 1.5% Amino Acids (Pentec Health) – sterility risk (2013)

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Class IIModerate

FDAMay 15, 2013Nationwide• Pentec Health

Nicardipine Hydrochloride Injection (West-ward) – Impurity Specification (2013)

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

FDAMay 13, 2013Nationwide• West-ward Pharmaceutical Corp.

Trace Mineral-5 MDV (Abrams Royal) – Bacterial Contamination (2013)

Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

FDAMay 13, 2013Nationwide• Abrams Royal Pharmacy

Warfarin Sodium Tablets (Zydus) – Tablet Specification Issue (2013)

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

FDAMay 13, 2013Nationwide• Zydus Pharmaceuticals USA Inc

Piperacillin Tazobactam Injection (Apotex) – Crystallization Risk (2013)

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

FDAMay 10, 2013Nationwide• Apotex Corp.

Dicopanol FusePaq Kit (Fusion) – Microbial Contamination (2013)

Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

Class IIModerate

FDAMay 8, 2013CA• Fusion Pharmaceuticals, LLC

Derma-Smoothe/FS Topical Oil (Hill) – Subpotent Drug (2013)

Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDAMay 7, 2013Nationwide• Hill Dermaceuticals, Inc.

Lightning ROD Capsules (Chang Kwung) – Unapproved Analogue (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

FDAMay 6, 2013Nationwide• Chang Kwung Products

Lightning ROD Capsules (Chang Kwung) – Unapproved Analogue (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

FDAMay 6, 2013Nationwide• Chang Kwung Products

Pure Herbs Protein Supplement (Pure Herbs) – Undeclared Milk Soy (2013)

Undeclared Allergen

Pure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product.

FDAMay 4, 2013Nationwide• Pure Herbs Ltd

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