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Showing 8641–8660 of 15081 results

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Cyproheptadine Hydrochloride Syrup (Lyne) – subpotency issue (2016)

Subpotency: product assayed and found OOS for cyproheptadine

Class IIILow

FDAJun 7, 2016NJ• Lyne Laboratories, Inc.

Nature Made D3 1000IU 350ct (Pharmavite) – Yeast/Mold Specs (2016)

Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Super B-Complex (Pharmavite) – Bacterial Contamination (2016)

Salmonella

Lot No. 1173146, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Lot No 1204001, exp. MAR 2018 of Nature Made(R) product may have possible Salmonella contamination.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Super B-Complex (Pharmavite) – Staphylococcus Contamination (2016)

Specific lots of Nature Made(R) product may have possible Staphylococcus aureus contamination.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Colostrum6 Capsules (Immune Tree) – Undeclared Milk (2016)

Undeclared Allergen

Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.

Class IIModerate

FDAJun 6, 2016Nationwide• Immune Tree, Inc (formerly ITG, Inc.)

Super B-Complex (Pharmavite) – Staphylococcus Contamination (2016)

Salmonella

Lot No. 1170987, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Lot No1204735, exp. MAR 2018 of Nature Made(R) product may have possible Salmonella contamination.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Nature Made D3 1000IU 100ct (Pharmavite) – Yeast/Mold Specs (2016)

Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Vitamin D3 (Pharmavite) – Yeast Mold Excess (2016)

Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Nature Made D3 1000IU 125ct (Pharmavite) – Yeast/Mold Specs (2016)

Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.

Class IIModerate

FDAJun 6, 2016Nationwide• Pharmavite

Sirolimus Tablets (Dr. Reddy's) – impurity secorapamycin (2016)

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Class IIILow

FDAJun 3, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Urea Cream (Exact-Rx) – product crystallization (2016)

Crystallization; complaints received by the manufacturer of crystals forming in product

Class IIILow

FDAJun 2, 2016Nationwide• Exact-Rx Inc

Ceftriaxone Injection (Aidarex) – manufacturing deviation (2016)

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

Class IIILow

FDAJun 1, 2016GA, IN• Aidarex Pharmaceuticals LLC

Ciprofloxacin Ophthalmic Solution (Aidarex) – impurity detected (2016)

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

Class IIILow

FDAJun 1, 2016Nationwide• Aidarex Pharmaceuticals LLC

Chlorhexidine Oral Rinse (Aidarex) – impurity detected (2016)

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

Class IIModerate

FDAJun 1, 2016CA, ND, PA +1 more• Aidarex Pharmaceuticals LLC

MitoXantrone Injection (Teva) – impurity D found (2016)

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

Class IIILow

FDAMay 31, 2016Nationwide• Teva North America

Irbesartan-Hydrochlorothiazide Tablets (Prinston) – incorrect lot number (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Class IIILow

FDAMay 30, 2016Nationwide• Prinston Pharmaceutical Inc

Pramipexole Extended Release Tablets (Par) – impurity concern (2016)

Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

Class IIILow

FDAMay 28, 2016Nationwide• Par Pharmaceutical