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Showing 1561–1580 of 3363 results

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Megestrol Suspension (Mckesson) – Subpotent Drug (2018)

Subpotent Drug: Out of specification for assay (stability testing)

FDAJan 29, 2018Nationwide• Mckesson Packaging Services

Fentanyl 25mcg Patch (Teva) – Degradation Risk (2018)

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

FDAJan 29, 2018Nationwide• Teva Pharmaceuticals USA

Fentanyl 75mcg Patch (Teva) – Degradation Risk (2018)

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Class IIILow

FDAJan 29, 2018Nationwide• Teva Pharmaceuticals USA

Fragrant Pear (IQ Produce) – Unapproved Pesticide (2018)

Firm was notified of unapproved pesticide - isocarbophos, on Fresh Fragrant Pears imported from China and fruit was released into commerce.

FDAJan 27, 2018CA• IQ PRODUCE, LLC

Cefuroxime Injection (JCB Laboratories) – Subpotent Drug (2018)

Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.

FDAJan 24, 2018Nationwide• JCB Laboratories LLC

Acne Treatment Concealer (Oxygen Development) – Superpotent Drug (2018)

Superpotent drug: failed assay throughout the stick after 6 months stability.

FDAJan 24, 2018Nationwide• Oxygen Development Llc

Ultane Sevoflurane (AbbVie) – Defective Container (2018)

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

FDAJan 22, 2018MS, OH• AbbVie Inc.

Oxycodone Tablets (Ascent Pharmaceuticals) – Labeling Error (2018)

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

FDAJan 22, 2018Nationwide• Ascent Pharmaceuticals, Inc.

Ciclopirox Cream (G&W Laboratories) – Product Discoloration (2018)

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

FDAJan 19, 2018Nationwide• G & W Laboratories, Inc.

Vecuronium Bromide Injection (Fresenius Kabi) – Impurity Specifications (2018)

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

FDAJan 16, 2018Nationwide• Fresenius Kabi USA, LLC

Tofu Breakfast Burrito (Rico Brand) – Undeclared Soy (2018)

Rico Brand is recalling Tofu Breakfast Burrito because it contains undeclared soy.

FDAJan 10, 2018IN, UT, VA• Rico Brand

Potato Buns (Grand Central Bakery) – Milk Labeling (2018)

Potato Buns label declares "Contains: wheat, dairy". Milk is declared in the ingredients statement, but not in the Contains statement.

FDAJan 10, 2018IN, WA• GRAND CENTRAL BAKERY INC

Hot Dog Buns (Grand Central Bakery) – Milk Labeling (2018)

Hot Dog Buns label declares "Contains: wheat, egg, dairy". Milk is declared in the ingredients statement, but not in the Contains statement.

FDAJan 10, 2018IN, WA• GRAND CENTRAL BAKERY INC

Seasoning Blend (Paris Foods) – Pesticide Contamination (2018)

The product has been recalled because it has the potential to be contaminated with a chemical pesticide residue.

FDAJan 3, 2018AL, IN• Paris Foods Corporation

Shitake Mushroom Slice (Vinh Sanh) – Undeclared Sulfites (2018)

Undeclared Allergen

Undeclared sulfites.

FDAJan 2, 2018AL, CA, CO +7 more• Vinh Sanh Trading Corp

Simvastatin Tablets 40mg (Hetero Labs) – foreign object risk (2017)

Presence of foreign substance: metallic razor blade was found in one bottle.

FDADec 22, 2017Nationwide• Hetero Labs, Ltd. - Unit III

Clobetasol Propionate Cream 0.05% (Taro) – content uniformity issue (2017)

Failed Content Uniformity Specifications

FDADec 21, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Methylphenidate Tablets 54mg (Osmotica) – Subpotent Drug (2017)

Subpotent Drug

FDADec 18, 2017Nationwide• Osmotica Pharmaceutical Corp

Methylphenidate Tablets 27mg (Osmotica) – Subpotent Drug (2017)

Subpotent Drug

FDADec 18, 2017Nationwide• Osmotica Pharmaceutical Corp

Wild Pacific Smoked Salmon (Barlean's) – Undeclared soy (2017)

Undeclared Allergen

REEF NET brand Wild Pacific Smoked Salmon, Ready-To-Eat product, is recalled due to undeclared soy lecithin. The firm used soy release agent but did not declare soy lecithin in the ingredients statement. There was no allergens "Contains" statement on affected product's label.

FDADec 18, 2017IN, WA• Barlean's Fishery Inc.

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