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Showing 2461–2480 of 3363 results

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ILL RIVER Bread Base (Heartland) – Undeclared Allergens (2015)

Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.

FDAAug 27, 2015IL, IN, IA +1 more• Heartland Products Inc.

Waveland Pancake Mix (Heartland) – Undeclared Allergens (2015)

Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.

FDAAug 27, 2015IL, IN, IA +1 more• Heartland Products Inc.

Roma's Italian Base (Heartland) – Undeclared Allergens (2015)

Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.

Class IIILow

FDAAug 27, 2015IL, IN, IA +1 more• Heartland Products Inc.

Turano Knead Dough Base (Heartland) – Undeclared Allergens (2015)

Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.

FDAAug 27, 2015IL, IN, IA +1 more• Heartland Products Inc.

Lamivudine Oral Solution (Silarx) – Labeling Error (2015)

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

FDAAug 21, 2015Nationwide• Silarx Pharmaceutical, Inc.

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Missing Safety Seal (2015)

Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.

FDAAug 21, 2015Nationwide• Akorn, Inc.

Gluten Free Cupcakes (Coquette's Bistro) – Labeling Mismatch (2015)

Labeling incorrect with conflicting information, state: Contains No Egg or Dairy, but then later states: Ingredients: Whole Milk and Eggs. Product does contain milk and eggs.

FDAAug 21, 2015CO, UT, VA• Coquette's Bistro and Bakery

Rifampin Injection (Akorn) – Impurity Specifications (2015)

Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.

FDAAug 20, 2015Nationwide• Akorn, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Ampicillin Capsules (Qualitest) – Labeling Issue (2015)

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

FDAAug 13, 2015OH• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine-Atorvastatin Tablets (Dr. Reddy's) – Subpotent Drug (2015)

Subpotent Drug: Subpotent atorvastatin.

FDAAug 13, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Methocarbamol Tablets (Golden State Medical) – Foreign Substance (2015)

Presence of Foreign Substance: Presence of hair.

FDAAug 11, 2015GA• Golden State Medical Supply Inc.

Herb De Provence (Piazza Produce) – Missing Ingredients (2015)

Product labeling does not contain a listing of ingredients.

FDAAug 7, 2015IL, IN, KY +2 more• PIAZZA PRODUCE, INC.

Garlic Salt (Piazza Produce) – Missing Ingredients (2015)

Product labeling does not contain a listing of ingredients.

FDAAug 7, 2015IL, IN, KY +2 more• PIAZZA PRODUCE, INC.

Curry Powder (Piazza Produce) – Missing Ingredients (2015)

Product labeling does not contain a listing of ingredients.

FDAAug 7, 2015IL, IN, KY +2 more• PIAZZA PRODUCE, INC.

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