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Showing 1941–1960 of 3363 results

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Starkey Spring Water – Arsenic Contamination (2016)

Starkey Spring Water, 16.9 fl oz. glass bottles, are recalled because 11.7 ppb of arsenic was detected in water sample.

FDADec 15, 2016CO, FL, IN +2 more• Starkey Water

Azelastine Nasal Spray (Roxane) – Droplet Size Problem (2016)

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

FDADec 14, 2016Nationwide• Roxane Laboratories, Inc.

Donepezil Hydrochloride Tablets (Sandoz Inc) – Subpotent Drug (2016)

Subpotent Drug: out of specification results for assay test.

Class IIILow

FDADec 13, 2016Nationwide• Sandoz Inc

VirtPrex Prenatal Tablets (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Extra-Virt Plus DHA Softgel (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Virt-Select Prenatal Softgels (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Virt-Advance Prenatal Softgels (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Novacort Gel Packets (Novum Pharma) – Subpotent Drug (2016)

Subpotent Drug: Out of specification result for pramoxine hydrochloride

FDADec 7, 2016Nationwide• Novum Pharma, LLC

INOVA Easy Pad (Cipher Pharmaceuticals) – Subpotent Formulation (2016)

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

FDADec 6, 2016AZ, CO, OH• Cipher Pharmaceuticals US LLC

Pentasa Capsules (Shire PLC) – Incorrect Tablet Mix (2016)

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

FDADec 2, 2016Nationwide• Shire PLC

Endure 400 Scrub-Stat (Ecolab) – Subpotent Solution (2016)

Subpotent Drug

FDADec 2, 2016Nationwide• Ecolab, Inc.

Risedronate Sodium Tablets (Teva) – Failed Dissolution (2016)

Failed Dissolution Specifications

FDADec 1, 2016Nationwide• Teva Pharmaceuticals USA

PROTONIX I.V. (Pfizer) – Subpotent Injection (2016)

Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

FDANov 22, 2016Nationwide• Pfizer Inc.

Toms of Maine Antiperspirant (Knowlton) – Labeling Error (2016)

Labeling: Label Mix Up- Incorrect back label applied to the product.

FDANov 22, 2016Nationwide• Les Emballages Knowlton Inc.

Sodium Ferric Gluconate (West-Ward) – Subpotent Drug (2016)

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.

FDANov 17, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Milk Chocolate Pretzels (First Source) – Incorrect Label (2016)

Milk Chocolate covered pretzels have incorrect rear label. The rear label is for the Dark Chocolate pretzels which lack allergen declaration.

FDANov 11, 2016MD, MA, NJ +3 more• First Source, LLC

Techni-Care Surgical Scrub (Care-Tech Labs) – Labeling Issue (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.

FDANov 8, 2016Nationwide• Care-Tech Laboratories, Inc.

Amoxicillin Suspension (West-Ward) – Labeling Error (2016)

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

FDANov 4, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Diltiazem HCl Capsules (Mylan) – Impurity Specifications (2016)

Failed Impurities/Degradation Specifications: OOS results for known compound.

FDANov 3, 2016Nationwide• Mylan Pharmaceuticals Inc.

Broccoli Cheddar Soup (Panera) – Foreign Object Risk (2016)

Presence of Foreign object

FDANov 2, 2016CA, CT, FL +5 more• Blount Fine Foods Corporation

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