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Showing 2161–2180 of 3363 results

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Candesartan Cilexetil (Amerisource) – Impurity Failure (2016)

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

FDAJan 26, 2016Nationwide• Amerisource Health Services

Tropicamide Ophthalmic Solution (Bausch & Lomb) – Missing Package Insert (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

FDAJan 18, 2016Nationwide• Bausch & Lomb, Inc.

Tropicamide Ophthalmic Solution (Bausch & Lomb) – Missing Package Insert (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Class IIILow

FDAJan 18, 2016Nationwide• Bausch & Lomb, Inc.

Cyclopentolate (Bausch & Lomb) – Missing Insert (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

FDAJan 18, 2016Nationwide• Bausch & Lomb, Inc.

Virt-Nate Prenatal (Virtus) – incorrect tablet imprint (2016)

Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).

FDAJan 15, 2016MI• Virtus Pharmaceuticals, Llc

Scotch Bonnet Pepper Relish (S & S Foods) – Packaging Defect (2016)

Some jars were reported to have swollen or leaking lids.

FDAJan 14, 2016OK• S & S Foods, Inc.

Risperidone Orally Disintegrating Tablets 2mg (Zydus) – impurity specs (2016)

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

FDAJan 14, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Norepinephrine Bitartrate (Pharmedium) – Subpotent Drug (2015)

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

FDADec 31, 2015Nationwide• Pharmedium Services, LLC

Norepinephrine Bitartrate (Pharmedium) – Subpotent Drug (2015)

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

FDADec 31, 2015Nationwide• Pharmedium Services, LLC

Candesartan Cilexetil Tablets (Sandoz) – Impurity Specifications (2015)

Failed Impurities/Degradation Specifications; 9 month stability timepoint

FDADec 31, 2015Nationwide• Sandoz Inc

Chocolate Chile Pecan Tart (Hail Merry) – Undeclared Ingredient (2015)

List of ingredient fails to include almond flour.

FDADec 28, 2015CA, CO, IA +5 more• Hail Merry LLC

Life-Line Docusate Calcium (National Vitamin Co Inc) – Label Mix-up (2015)

Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.

FDADec 18, 2015Nationwide• National Vitamin Co Inc

Ranitidine Syrup (Bio-pharm) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

FDADec 17, 2015Nationwide• Bio-pharm, Inc.

VP-CH-PNV Prenatal/Postnatal (Virtus Pharmaceuticals) – Leaking Capsules (2015)

Defective Delivery System: Product may contain leaking capsules.

FDADec 17, 2015Nationwide• Virtus Pharmaceuticals, Llc

Mote Blanco (FABI-SAA) – Sulfite Disclosure (2015)

Undeclared Allergen

Fabi-Saa Mote Blanco contains undeclared sulfites at 2.61 mg.

FDADec 16, 2015NJ, NY• FABI - SAA Inc.

English Breakfast Tea (Twinings) – Packaging Error (2015)

Twinings English Breakfast Black Tea 12ct Kcups, were packaged in cartons stating Twinings English Breakfast Black Tea Decaffeinated.

FDADec 16, 2015CA, CO, CT +18 more• Twinings North America, Inc.

Lindane Lotion (Morton Grove Pharmaceuticals) – Out of Specification (2015)

Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

FDADec 15, 2015Nationwide• Morton Grove Pharmaceuticals, Inc.

Triple Ginger Brew (Trader Joe's) – Bottle Burst (2015)

Trader Joes recalling Triple Ginger Brew due to reports of unopened bottles potentially bursting.

FDADec 15, 2015Nationwide• Trader Joes Company

FATwater Lemon (Bulletproof) – Microbial Growth (2015)

FATwater bottles, Lemon flavor, are recalled due to microbial growth detection. No E.coli or other pathogens were detected.

FDADec 10, 2015Nationwide• Bulletproof Digital Inc

FATwater Tangerine (Bulletproof) – Microbial Growth (2015)

FATwater bottles, Tangerine flavor, are recalled due to microbial growth detection. No E.coli or other pathogens were detected.

FDADec 10, 2015Nationwide• Bulletproof Digital Inc

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