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Showing 2061–2080 of 3363 results

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Carvediol 12.5mg Tablets (Sun Pharma) – Failed Impurities Test (2016)

Failed Impurities/Degradation Specifications

FDAJun 27, 2016Nationwide• Sun Pharmaceutical Industries, Inc.

Zero to Hero BBQ Rub (Old World Spices) – undeclared MSG (2016)

Some bottles of barbeque seasoning without a statement noting the product contains MSG (monosodium glutamate).

FDAJun 21, 2016IN, MN, MO +1 more• Old World Spices & Seasonings Inc

Methylprednisolone Tablets (Jubilant Cadista) – incorrect expiration date (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

Class IIILow

FDAJun 13, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Seconal Sodium Capsules (Valeant) – missing anaphylaxis warning (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

FDAJun 10, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Honey with Comb (Goya) – Chemical Contamination (2016)

Goya Honey with Comb product tested by FDA showed presence of 2, 6 Dichlorobenzamide which is not EPA registered for use in honey.

FDAJun 7, 2016PR• Tradewind Foods de Puerto Rico Inc.

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

Subpotency: product assayed and found OOS for cyproheptadine

FDAJun 7, 2016NJ• Lyne Laboratories, Inc.

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

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

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

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.

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.

FDAJun 1, 2016Nationwide• Aidarex Pharmaceuticals LLC

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

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

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.

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.

FDAMay 28, 2016Nationwide• Par Pharmaceutical

Remeven Cream (Stratus) – product crystallization (2016)

Crystallization; Complaints that cream appears to have crystallized

FDAMay 26, 2016Nationwide• Stratus Pharmaceuticals Inc

Dandruff Care System (Taro Pharmaceuticals) – Subpotent Active Ingredient (2016)

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

FDAMay 26, 2016Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Lisinopril Tablets 30mg (Sandoz) – Incorrect Package Insert (2016)

Labeling: Incorrect or Missing Package Insert

FDAMay 25, 2016Nationwide• Sandoz Inc

Lodrane D (Valeant) – Mislabeled Carton Packaging (2016)

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

FDAMay 23, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Oxycodone HCl Oral Solution (West-Ward) – Failed Impurities Test (2016)

Failed Impurities/Degradation Specification; 9 month stability

FDAMay 19, 2016Nationwide• West-Ward Columbus Inc

Doxycycline Capsules 40mg (Galderma) – Missing Lot Details (2016)

Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.

FDAMay 19, 2016Nationwide• Galderma Laboratories, L.P.

Divalproex Sodium Tablets (Teva) – Failed Tablet Specs (2016)

Failed Tablet/Capsule Specifications

FDAMay 18, 2016Nationwide• Teva North America

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