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Showing 9281–9300 of 14370 results

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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

Thermo FX Barely Legal (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

MIDAZOLAM HCl Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Lamivudine Oral Solution (Silarx) – Labeling Error (2015)

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

FDAAug 21, 2015Nationwide• Silarx Pharmaceutical, Inc.

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Missing Safety Seal (2015)

Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.

FDAAug 21, 2015Nationwide• Akorn, Inc.

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Lidocaine HCl Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Midazolam HCl Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Heparin Sodium Injection (Cantrell) – Stability Concern (2015)

Stability Data Does Not Support Expiry

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Atropine Sulfate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Asthmanefrin Racepinephrine Starter Kit (Nephron) – Discoloration (2015)

Discoloration

Class IIModerate

FDAAug 21, 2015Nationwide• Nephron Pharmaceuticals Corp.

Ipratropium Bromide Albuterol Inhalation (Nephron) – Sterility Risk (2015)

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

Class IIModerate

FDAAug 21, 2015Nationwide• Nephron Pharmaceuticals Corp.

Midazolam HCl Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Heparin Sodium Injection (Cantrell) – Stability Concern (2015)

Stability Data Does Not Support Expiry

Class IIModerate

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

Asthmanefrin Racepinephrine Refills (Nephron) – Discoloration (2015)

Discoloration

Class IIModerate

FDAAug 21, 2015Nationwide• Nephron Pharmaceuticals Corp.

Fentanyl Citrate Injection (Cantrell) – Subpotent Drug (2015)

Subpotent Drug

FDAAug 21, 2015Nationwide• Cantrell Drug Company

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