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Showing 2081–2100 of 3363 results

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Mycophenolate Mofetil Powder (Attix) – FDA Registration Issue (2016)

cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration

FDAMay 18, 2016CO• Attix Pharmaceuticals Inc

Moisture Surge Tinted Moisturizer SPF 15 (Clinique) – Subpotent Sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

FDAMay 17, 2016Nationwide• Clinique International

Moisture Surge Tinted Moisturizer (Clinique) – Subpotent Sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

Class IIILow

FDAMay 17, 2016Nationwide• Clinique International

Moisture Surge Tinted Moisturizer SPF 15 (Clinique) – Subpotent Sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

FDAMay 17, 2016Nationwide• Clinique International

Moisture Surge Tinted Moisturizer (Clinique) – subpotent sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

FDAMay 17, 2016Nationwide• Clinique International

Moisture Surge Tinted Moisturizer (Clinique) – subpotent sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

FDAMay 17, 2016Nationwide• Clinique International

Moisture Surge Tinted Moisturizer SPF 15 (Clinique) – Subpotent Sunscreen (2016)

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

FDAMay 17, 2016Nationwide• Clinique International

Prenatal Supplement (Virtus) – Leaking Capsules (2016)

Defective delivery system: Softgel capsules are leaking.

FDAMay 16, 2016Nationwide• Virtus Pharmaceuticals, Llc

Hyoscyamine Sulfate Tablets (Virtus Pharmaceuticals) - Contamination Risk (2016)

Chemical Contamination: Bottles may contain broken dessicants

FDAMay 13, 2016Nationwide• Virtus Pharmaceuticals, Llc

Pyridoxine HCL Injection (Medaus) – Sterility Concern (2016)

Lack of Assurance of Sterility

FDAMay 13, 2016Nationwide• Medaus, Inc.

Homestyle Dressing (Dorothy Lynch) – Product Return (2016)

The firm issued a press release on May 6, 2016, which encouraged consumers with affected bottles to return the product to the store for a refund. The recall will extend through the wholesale and retail distribution chain via scripted phone notification. The firm has informed distributors/retails to remove the product from shelves and track by using the best by date and sku. Products should be destroyed. The information has been posted on the firm website.

FDAMay 6, 2016CO, IN, IA +10 more• Tasty Toppings Inc

Benzphetamine Tablets 50mg (KVK-Tech) – Tablet Discoloration (2016)

Discoloration: presence of scuffing marks on tablets.

FDAMay 5, 2016Nationwide• KVK-Tech, Inc.

Dicloxacillin Sodium Capsules 250mg (Sandoz) – impurity specification (2016)

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

FDAMay 2, 2016Nationwide• Sandoz, Inc

Dicloxacillin Sodium Capsules 500mg (Sandoz) – impurity specification (2016)

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

FDAMay 2, 2016Nationwide• Sandoz, Inc

3 Seed Crispbreads (Kracker) – Milk Labeling Error (2016)

Milk declared in the ingredient statement although the product does not contain milk.

FDAApr 29, 2016CA, IL, IA +7 more• Kracker Enterprises, LLC

Hectorol Injection (Genzyme) – incorrect barcode (2016)

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

FDAApr 27, 2016MI, NJ, PA• Genzyme Corporation / Genzyme Biosurgery

CVS Acid Controller (Dr. Reddy's) – Impurity Specification Failure (2016)

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

FDAApr 22, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Acetaminophen & Codeine Tablets (A-S Medication) – Incorrect Label (2016)

Labeling: Not elsewhere classified - count on the label was incorrect.

FDAApr 22, 2016VA• A-S Medication Solutions LLC.

SKY Aspirin Chewables (Mckesson) – Labeling Mix-up (2016)

Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.

FDAApr 12, 2016Nationwide• Mckesson Packaging Services

Colby Jack Cheese (MSU Dairy) – Metal Fragment Risk (2016)

Michigan State University Dairy is conducting a voluntary recall of Colby Jack cheese due to the potential for metal fragments to be present in the finished products.

FDAApr 11, 2016AL, AZ, CA +31 more• Msu Dept Of Fd Sci Dairy Plant

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