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Showing 9261–9280 of 14370 results

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Gaisantak Bati (Butala) – Heavy Metal Contamination (2015)

The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.

FDAAug 27, 2015CT, FL, HI +8 more• Butala Emporium, Inc.

Chitrakadi Bati (Butala) – Heavy Metal Contamination (2015)

The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.

FDAAug 27, 2015CT, FL, HI +8 more• Butala Emporium, Inc.

Bromfenac Ophthalmic Solution (Apotex) – sterility failure (2015)

Lack of Assurance of Sterility: Failed preservative effectiveness testing

Class IIModerate

FDAAug 25, 2015Nationwide• Apotex Inc.

Lidocaine HCl Injection (Hospira) – particulate matter contamination (2015)

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Class IIModerate

FDAAug 25, 2015Nationwide• Hospira, Inc.

Thin and Slim Extreme Stack (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Blephamide Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Methyldrene Original 25 (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Xcellerator (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Doxycycline Hyclate Tablets (C.O. Truxton) – incorrect bar code (2015)

Labeling: Wrong Bar Code

Class IIModerate

FDAAug 24, 2015Nationwide• C. O. Truxton

Refresh Lacri-Lube (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Thin and Slim Burn Fat Now Dietary Supplement (Novacare) – Unapproved Supplement (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Black Widow 25 Fat Burner (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Thin and Slim Naturally AM Supplement (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

MetaPro 360 Metabolic Accelerator (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Thin and Slim MaxOut Fat Burner (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

FML Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Store Thin and Slim Fat Burner (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

TruTrim (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

Refresh P.M. Eye Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Thin and Slim Fataway Ultimate Stack (Novacare) – undeclared ingredient (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

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