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Showing 11501–11520 of 14370 results

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Performance Plus (Good Herbs) – Manufacturing Violations (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Mojo Risen Capsules (Eugene Oregon) – Undeclared Sildenafil (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

FDAMay 5, 2014FL, IL, IN +8 more• Eugene Oregon, Inc.

Fosphenytoin Sodium Injection (Fresenius) – Glass Particulates (2014)

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Class IIModerate

FDAMay 2, 2014Nationwide• Fresenius Kabi USA, LLC

Fosphenytoin Sodium Injection (Fresenius) – Glass Particulates (2014)

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Class IIModerate

FDAMay 2, 2014Nationwide• Fresenius Kabi USA, LLC

Dextroamphetamine Tablets (Teva) – Impurity Specifications (2014)

Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.

Class IIModerate

FDAMay 1, 2014Nationwide• Teva Pharmaceuticals USA

Captain Kratom Gold XL Capsules (Prep Enterprises) – Kratom Content (2014)

Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa).

Class IIModerate

FDAMay 1, 2014AL, AZ, CA +15 more• Prep Enterprises Llc

Calcitriol Oral Solution (Boehringer Ingelheim) – Impurity Specification (2014)

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Class IIModerate

FDAMay 1, 2014Nationwide• Boehringer Ingelheim Roxane Inc

Tatiomax Injection (Flawless Beauty) – Unapproved Antidote (2014)

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.

Class IIModerate

FDAApr 29, 2014Nationwide• Flawless Beauty LLC

Laroscorbine Platinium (Flawless Beauty) – Unapproved Antidote (2014)

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.

Class IIModerate

FDAApr 29, 2014Nationwide• Flawless Beauty LLC

Vitamin C Injection (Flawless Beauty) – Unapproved Treatment (2014)

Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.

Class IIModerate

FDAApr 29, 2014Nationwide• Flawless Beauty LLC

Saluta Glutathione (Flawless Beauty) – Unapproved Antidote (2014)

Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

Class IIModerate

FDAApr 29, 2014Nationwide• Flawless Beauty LLC

Red Yeast Rice Supplement (Independent Nutrition) – Excessive Lovastatin (2014)

Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.

Class IIModerate

FDAApr 29, 2014Nationwide• Independent Nutrition Center, Inc.

Relumins Advanced Glutathione (Flawless Beauty) – Unapproved Injectable (2014)

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.

Class IIModerate

FDAApr 29, 2014Nationwide• Flawless Beauty LLC

TEV-TROPIN Injection (Ferring) – Silicone Oil Contamination (2014)

Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.

Class IIModerate

FDAApr 28, 2014PA• Ferring Pharmaceuticals Inc

PediaCare Day & Night Cold (Prestige Brands) – Solution Precipitate (2014)

Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

FDAApr 25, 2014Nationwide• Prestige Brands Holdings

Diclofenac Sodium Tablets (Actavis) – Tablet Split Risk (2014)

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Class IIModerate

FDAApr 24, 2014Nationwide• Actavis Laboratories, FL, Inc.

Famotidine Injection (Baxter) – Particulate Matter (2014)

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Class IIModerate

FDAApr 24, 2014Nationwide• Baxter Healthcare Corp.

Diclofenac Sodium Tablets (Actavis) – Tablet Split Risk (2014)

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Class IIModerate

FDAApr 24, 2014Nationwide• Actavis Laboratories, FL, Inc.

Liothyronine Sodium Tablets (SigmaPharm) – Cross Contamination (2014)

Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.

Class IIModerate

FDAApr 22, 2014Nationwide• SigmaPharm Laboratories LLC

Marcaine Injection (Hospira) – metal particle contamination (2014)

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

FDAApr 21, 2014Nationwide• Hospira Inc.

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