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Showing 2821–2840 of 3363 results

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Hot & Spicy Seasoning (Gold Medal) – Incorrect packaging (2014)

Cajun Savory was packed in Hot & Spicy package

FDAMar 21, 2014AZ, CA, IN +7 more• Gold Medal Products

Risperidone Oral Solution 1mg/mL (Apotex) – Impurity Specification (2014)

Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

FDAMar 20, 2014Nationwide• Apotex Inc.

Papaverine Combination Solution (Hollis) – Incorrect Labeling (2014)

Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

Class IIILow

FDAMar 17, 2014MS, MO, TN +1 more• John W Hollis Inc

Polidocanol 1% Solution (Hollis) – Incorrect Labeling (2014)

Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

FDAMar 17, 2014MS, MO, TN +1 more• John W Hollis Inc

Ritalin HCl (Novartis) – incorrect package insert (2014)

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

FDAMar 3, 2014Nationwide• Novartis Pharmaceuticals Corp.

Ritalin HCl (Novartis) – Incorrect Package Insert (2014)

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

FDAMar 3, 2014Nationwide• Novartis Pharmaceuticals Corp.

Venlafaxine Capsules (McKesson) – dissolution failure (2014)

Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.

FDAMar 3, 2014Nationwide• McKesson Packaging Services

Advil PM Caplets (Pfizer) – Subpotent Diphenhydramine (2014)

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

FDAFeb 26, 2014Nationwide• Pfizer Us Pharmaceutical Group

Green Tea Pumpkin Seeds (Asian Taste) – Undeclared Ingredient (2014)

Walong Marketing, Inc. initiated the recall of Asian Taste Green Tea Pumpkin Seeds because it contains the ingredient sodium copper chlorophyllin, not permitted for use in food or food products sold in the U.S.

FDAFeb 20, 2014Nationwide• Walong Marketing, Inc.

Nicotine Polacrilex Lozenge 4mg (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Nicorette Lozenges Mini (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Nicorette & NicoDerm CQ (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Nicotine Polacrilex Lozenge 2mg (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Nicorette Product Line (GlaxoSmithKline) – Specification Failure (2014)

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

FDAFeb 20, 2014Nationwide• GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Atripla (Gilead) – Foreign Substance Risk (2014)

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

FDAFeb 19, 2014Nationwide• Gilead Sciences, Inc.

Tivicay Tablets (Viiv) – Cross Contamination (2014)

Cross Contamination with Other Products: Product contains Promacta (eltrombopag).

FDAFeb 11, 2014Nationwide• Viiv Healthcare Company

QVAR Inhalation Aerosol (Teva) – Impurity Specification (2014)

Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point

FDAFeb 11, 2014Nationwide• Teva Pharmaceuticals USA

Photofrin Injection (Pinnacle) – Expiration Date Error (2014)

Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.

FDAFeb 10, 2014Nationwide• Pinnacle Biologics Inc

Parsnips (Heart of Valley) – Pesticide Tolerance Exceeded (2014)

Parsnips were found to be above tolerance, maximum residue level, for the pesticide linuron.

FDAFeb 8, 2014IA, KS, MN +2 more• Ed Fields & Sons, Inc

Breakfast Bowl (Simplot) – Undeclared Preservative (2014)

Raw material supplier accidently added sodium benzoate to the salsa used in manufacturing the finished product. Sodium benzoate was not declared on the ingredient statement of both the raw material and finished product.

FDAFeb 7, 2014IN, OH• J. R. Simplot Co. Corporate HQ

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