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Showing 14721–14740 of 15081 results

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Sodium Chloride Injection (Hospira) – Particulate matter risk (2012)

Presence of Particulate Matter; product may contain fibrous material

FDAAug 31, 2012Nationwide• Hospira Inc.

EphBurn 25 (Brand New Energy) – Unapproved drug (2012)

Brand New Energy is recalling all lot codes of EphBurn 25 because it may contain ephedrine alkaloids, making it an unapproved drug.

FDAAug 30, 2012CO, ID, KS +1 more• Brand New Energy, LLC

BiCNU Carmustine Injection (Bristol-Myers Squibb) – Superpotent drug (2012)

Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.

Class IHigh

FDAAug 29, 2012Nationwide• Bristol-myers Squibb Company

Propofol Injectable Emulsion (Hospira) – Particulate matter detected (2012)

Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.

Class IIModerate

FDAAug 29, 2012Nationwide• Hospira Inc.

Diazepam Injection (Hospira) – Sterility concern (2012)

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Class IIModerate

FDAAug 28, 2012Nationwide• Hospira Inc.

Morphine Sulfate Injection (Hospira) – Sterility concern (2012)

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

Class IIModerate

FDAAug 28, 2012Nationwide• Hospira Inc.

Atrovent HFA Inhalation Aerosol (Dispensing Solutions) – Label mix-up (2012)

Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol

Class IIModerate

FDAAug 28, 2012IN, WI• Dispensing Solutions, Inc

IQF PND Shrimp (Chang Jiang) – Unapproved Antibiotic (2012)

Chang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic.

FDAAug 27, 2012AZ, CA, UT• Chang Jiang Seafood Ca Inc

Novarel Chorionic Gonadotropin (Ferring Pharmaceuticals) – Labeling omission (2012)

Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.

FDAAug 23, 2012Nationwide• Ferring Pharmaceuticals Inc

Mojo Nights (Evol Nutrition) – Unapproved ingredients (2012)

Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.

FDAAug 23, 2012Nationwide• Evol Nutrition

Mojo Nights for Her (Evol Nutrition) – Unapproved ingredients (2012)

Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.

FDAAug 23, 2012Nationwide• Evol Nutrition

Venlafaxine ER (Stat Rx USA) – Labeling error (2012)

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

FDAAug 23, 2012GA, TN• Stat Rx USA

Nimodipine Capsules (Caraco) – Crystallization issue (2012)

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

Class IIModerate

FDAAug 21, 2012MI• Caraco Pharmaceutical Laboratories Ltd.

Atorvastatin Calcium Tablets (Ranbaxy) – Foreign tablet contamination (2012)

Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Class IIModerate

FDAAug 21, 2012Nationwide• Ranbaxy Inc.

ProBalance Protein Shake (Protica) – Botulinum contamination risk (2012)

Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum

Class IIModerate

FDAAug 17, 2012Nationwide• Protica, Inc

ProBalance Protein (Protica) – Botulinum contamination risk (2012)

Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum

Class IIModerate

FDAAug 17, 2012Nationwide• Protica, Inc

Major Oral Peroxide (Axcentria) – Unstable Expiration (2012)

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

FDAAug 17, 2012MI• Axcentria Pharmaceuticals LLC

Capex Shampoo (Galderma) – Subpotent Medication (2012)

Subpotent; fluocinolone acetonide.

FDAAug 15, 2012Nationwide• Galderma Laboratories, L.P.

HYDROmorphone HCl Injection (Hospira) – Overfilled Cartridge (2012)

Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.

FDAAug 15, 2012Nationwide• Hospira Inc.

Prometh VC Plain (Actavis) – Stability Degradation (2012)

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

FDAAug 14, 2012Nationwide• Actavis Mid Atlantic LLC

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