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Showing 11401–11420 of 14370 results

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Mircette (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Kariva (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Brevibloc (Baxter) – Particle Contamination (2014)

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Class IIModerate

FDAJun 16, 2014Nationwide• Baxter Healthcare Corp.

Venlafaxine (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Class IIModerate

FDAJun 12, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Captomer (Thorne) – Unapproved Supplement (2014)

Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.

Class IIModerate

FDAJun 12, 2014Nationwide• Thorne Research Inc

Captomer-250 (Thorne) – Unapproved Supplement (2014)

Class IIModerate

FDAJun 12, 2014Nationwide• Thorne Research Inc

DENBLAN (Estee Lauder) – Stability Data Issue (2014)

Stability Data Does Not Support Expiry

Class IIILow

FDAJun 6, 2014Nationwide• Estee Lauder Inc

Carbidopa Levodopa (Teva) – Tablet Specification (2014)

Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.

Class IIModerate

FDAJun 5, 2014Nationwide• Teva Pharmaceuticals USA

APLENZIN (Valeant) – Missing Package Insert (2014)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAJun 5, 2014Nationwide• Valeant Pharmaceuticals North America LLC

APLENZIN (Valeant) – Missing Package Insert (2014)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAJun 5, 2014Nationwide• Valeant Pharmaceuticals North America LLC

APLENZIN (Valeant) – Missing Package Insert (2014)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAJun 5, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Ferrous Gluconate Tablets (National Vitamin) – Mislabeled (2014)

National Vitamin is recalling Nature's Blend Ferrous Gluconate Tablets because they are mislabeled on the front panel with 65 mg of elemental iron. The side panel and the tablets inside the bottle have the correct label with 36mg of elemental iron per tablet.

Class IIModerate

FDAJun 4, 2014Nationwide• National Vitamin Co Inc

Atorvastatin (Unit Dose) – Tablet Mix-up (2014)

Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium

Class IIModerate

FDAJun 2, 2014PA• Unit Dose Solutions Inc

Soliris (Alexion) – Particle Contamination (2014)

Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.

Class IHigh

FDAJun 2, 2014Nationwide• Alexion Pharmaceuticals, Inc.