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Showing 13541–13560 of 14370 results

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MIC + B12 (The Compounding Shop) – sterility concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

Mitomycin (The Compounding Shop) – sterility concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

Betamethasone Injectable (Compounding Shop) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

Praziquantel Injectable (Compounding Shop) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

Phosphatidyl Choline Injectable (Compounding Shop) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

B-Complex Injectable (Compounding Shop) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMay 2, 2013CA, FL, ME +1 more• THE COMPOUNDING SHOP, INC.

SexVoltz (Beamonstar) – unapproved ingredients (2013)

Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

FDAMay 1, 2013Nationwide• Beamonstar Products

Velextra (Beamonstar) – unapproved ingredients (2013)

Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

FDAMay 1, 2013Nationwide• Beamonstar Products

XYMOGEN EP Dietary Supplement (XYMOGEN) – Undeclared Allergens (2013)

Undeclared Soy and Milk on the label.

FDAMay 1, 2013AL, AK, AZ +39 more• Atlantic Pro Nutrients, Inc. dba XYMOGEN

Levoxyl 88mcg Tablets (Pfizer) – Subpotent Medication (2013)

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Class IIModerate

FDAApr 30, 2013Nationwide• King Legacy, a wholly owned subsidiary of Pfizer

Levoxyl 175mcg Tablets (Pfizer) – Subpotent Medication (2013)

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Class IIModerate

FDAApr 30, 2013Nationwide• King Legacy, a wholly owned subsidiary of Pfizer

Levoxyl 137mcg Tablets (Pfizer) – Subpotent Medication (2013)

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Class IIModerate

FDAApr 30, 2013Nationwide• King Legacy, a wholly owned subsidiary of Pfizer

Black Ant Supplement (American Lifestyle) – Undeclared Ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

FDAApr 30, 2013Nationwide• American Lifestyle.Com

HydrOXYzine (Hi-Tech Pharmacal) – subpotent medication (2013)

Subpotent; 24 month stability test station

FDAApr 30, 2013Nationwide• Hi-Tech Pharmacal Co., Inc.

DOBUTamine Injection (Hospira) – Container Leaking (2013)

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

Class IIModerate

FDAApr 30, 2013Nationwide• Hospira Inc.

Vicerex Sexual Enhancer (American Lifestyle) – Undeclared Ingredients (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

FDAApr 30, 2013Nationwide• American Lifestyle.Com

Cornea Coat Syringe (Insight Instruments) – Unapproved Medical Device (2013)

Marketed without an Approved NDA/ANDA.

Class IIModerate

FDAApr 24, 2013Nationwide• Insight Instruments, Inc.

Ropinirole Tablets (Mylan) – Incorrect Labeling (2013)

Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..

Class IIModerate

FDAApr 22, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate Tablets (Walmart) – Label Strength Error (2013)

Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.

Class IIModerate

FDAApr 22, 2013Nationwide• Legacy Pharmaceutical Packaging LLC

Lidocaine Injection (Nora Apothecary) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAApr 22, 2013Nationwide• Nora Apothecary and Alternative Therapies, Inc.

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