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Showing 3101–3120 of 3363 results

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Junel Fe Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Errin Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Lam Sheng Kee Mini Sausage (S & M International) – undeclared FD&C (2013)

Undeclared Allergen

The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Mini Sausage contains undeclared FD&C Red #40 and undeclared minced fish (unknown fish species)

FDAMar 15, 2013NY• S & M International Inc

Seasonale Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Camrese Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 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.

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.

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.

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.

Golden Flower Dried Ginger (Prosperity Resources) – Regulatory Violation (2013)

The Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law.

FDAMar 11, 2013IN, NY• Prosperity Resources International, Inc.

Opalescence Treswhite Supreme Kit (Ultradent) – incorrect shelf life (2013)

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

FDAMar 8, 2013AL, CA, GA +10 more• Ultradent Products, Inc.

Myoflex Pain Relieving Cream (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

4 Way Fast Acting Nasal Spray (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

4 Way Saline Moisturizing Mist (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

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

4 Way Nasal Decongestant Spray (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

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.

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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