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Showing 27701–27720 of 29086 results

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Cocoa~Latte Hot Drink Maker (Focus Products) – potential lead exposure (2012)

The Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead.

Class IIModerate

FDANov 17, 2012Nationwide• Focus Products Group Llc

Sanh Yuan Preserved Plum Candy (Cho Fuku Group) – high lead levels (2012)

CHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead.

Class IIModerate

FDANov 16, 2012CA, WA• Cho Fuku Group (usa) Inc

Butter Flavor (Bakery Cash & Carry) – missing ingredient labels (2012)

The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Yellow#5, Yellow #6 and Red #40

Class IIModerate

FDANov 15, 2012PR• Bakery Cash & Carry Inc.

Brandy Flavor (Bakery Cash & Carry) – missing ingredient labels (2012)

The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40, Yellow#5, Yellow #6, Blue#1 and Sulfites.

Class IIModerate

FDANov 15, 2012PR• Bakery Cash & Carry Inc.

Propofol Injectable Emulsion (Hospira) – particulate matter (2012)

Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

Class IIModerate

FDANov 15, 2012Nationwide• Hospira Inc.

Butter Cream (Bakery Cash & Carry) – Undeclared ingredients (2012)

The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: The ingredient partially hydrogenated vegetable oil contains soybean oil as a sub-ingredient.

Class IIModerate

FDANov 15, 2012PR• Bakery Cash & Carry Inc.

Levothyroxine Tablets (Physicians Total) – subpotent medication (2012)

Subpotent; 15 month stability (by mfr)

Class IIModerate

FDANov 15, 2012GA, OH• Physicians Total Care, Inc.

Dairy Aid Enzyme Supplement (Cardinal Health) – incorrect strength (2012)

The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.

Class IIModerate

FDANov 13, 2012NJ, NY• Cardinal Health

Atorvastatin Tablets 10mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Atorvastatin Tablets 40mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Atorvastatin Tablets 20mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Vicks NyQuil (Procter & Gamble) – illegible labeling (2012)

Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.

Class IIModerate

FDANov 8, 2012Nationwide• Procter & Gamble Co

VIVITROL Injection (Alkermes) – sterility risk (2012)

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Class IIModerate

FDANov 6, 2012Nationwide• Alkermes, Inc.

Raw Sauerkraut Kimchi (Beagle Bay Organics) – Mixer Bolt Missing (2012)

Cracker Industries, LLC dba Beagle Bay Organics recalled their Raw Sauerkraut, Kimchi due to a bolt that was found missing from the rotation mixer.

Class IIModerate

FDANov 6, 2012FL, IN• Cracker Industries, LLC

Tramadol Tablets (Caraco) – foreign tablet contamination (2012)

Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.

Class IIModerate

FDANov 5, 2012Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Pradaxa Capsules (Boehringer) – container damage (2012)

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

Class IIModerate

FDANov 5, 2012Nationwide• Boehringer Ingelheim Roxane Inc

Gingerbread Cake (Zingerman's) – Undeclared Milk/Wheat (2012)

Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.

Class IIModerate

FDANov 2, 2012MI, OH• Zingerman's Bakehouse, Inc.

Big O Cookie Jrs. (Zingerman's) – undeclared allergens (2012)

Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.

Class IIModerate

FDANov 2, 2012MI, OH• Zingerman's Bakehouse, Inc.

Funky Chunky Chocolate Cookie Jrs. (Zingerman's) – Undeclared Milk/Wheat (2012)

Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.

Class IIModerate

FDANov 2, 2012MI, OH• Zingerman's Bakehouse, Inc.

Pound Cake (Zingerman's) – Undeclared Wheat (2012)

Zingerman's BAKEHOUSE pastry labels were found not identifying the source of flour as wheat.

Class IIModerate

FDANov 2, 2012MI, OH• Zingerman's Bakehouse, Inc.

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