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Showing 14481–14500 of 15081 results

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NewChapter Probiotic Elderberry – Undeclared Soy (2013)

Undeclared Allergen

The product may contain an undeclared allergen soy

FDAMar 13, 2013AK, AZ, CA +35 more• New Chapter, Inc.

Portia Tablets (Teva) – Appearance Specification Failure (2013)

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

FDAMar 12, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Jolessa Tablets (Teva) – Appearance Specification Failure (2013)

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

Class IIILow

FDAMar 12, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Liothyronine Tablets (Perrigo) – Stability Testing Failure (2013)

Failed Impurities/Degradation Specifications: 3 month stability testing.

FDAMar 12, 2013Nationwide• L. Perrigo Co.

Piracetam & Choline Capsules (Palmer Natural) - Unapproved Drugs (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Aniracetam and Choline Capsules (Palmer Natural) - Unapproved Drugs (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

BoostYourGrade Capsules (Palmer) – Unapproved Drug (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Lisinopril Hydrochlorothiazide Tablets (Gsms) - Foreign Substance (2013)

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer

Class IIModerate

FDAMar 11, 2013Nationwide• Gsms

Night Bullet Capsules (Green Planet) – Unapproved Ingredients (2013)

Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.

FDAMar 11, 2013Nationwide• Green Planet Inc

Brain Defogger Capsules (Palmer) – Unapproved Drug (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Aniracetam & Choline Capsules (Palmer Natural) - Unapproved Drugs (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Acetic Acid Otic Solution (Hi-Tech Pharmacal) - Subpotent Drug (2013)

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

FDAMar 11, 2013Nationwide• Hi-Tech Pharmacal Co., Inc.

Oxiracetam & Choline Capsules (Palmer) – Unapproved Drug (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Nootropa Cognitive Supplement (Palmer Natural) - Unapproved Drugs (2013)

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Class IIModerate

FDAMar 11, 2013CA, FL, ID• Palmer Natural Products

Nupercainal Ointment (Novartis) - Illegible Lot Number (2013)

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

FDAMar 7, 2013Nationwide• Novartis Consumer Health

Rifadin Capsules (Sanofi US) - Low Fill Volume (2013)

Subpotent drug: low fill volume in some of the capsules

Class IIModerate

FDAMar 7, 2013Nationwide• Sanofi US

Venlafaxine Tablets (Zydus) - Broken Tablet Defect (2013)

Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.

Class IIModerate

FDAMar 5, 2013Nationwide• Zydus Pharmaceuticals USA Inc

Add a Scoop Probiotic (Juice Bar Solutions) – GMO claim (2013)

It was discovered that label for Add a Scoop Probiotic stated that it was GMO free, however manufacturers paperwork did not support the claim.

FDAMar 4, 2013AZ, CA, FL +7 more• Juice Bar Solutions

Voltaren Gel (Physicians Total Care) - Illegible Lot Number (2013)

Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.

FDAMar 2, 2013Nationwide• Physicians Total Care, Inc.

Fenofibric Acid Tablets (Mutual Pharmaceutical) – Incorrect Labeling (2013)

Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots

FDAFeb 27, 2013Nationwide• Mutual Pharmaceutical Company, Inc.

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