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Showing 10441–10460 of 14370 results

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Simvastatin Tablets 40mg (Micro Labs) – Impurity Specification (2014)

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

FDADec 4, 2014Nationwide• Micro Labs Usa, Inc S

MitoXANTRONE Injection (Hospira) – Stability Failure (2014)

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

FDADec 3, 2014Nationwide• Hospira Inc.

Tikosyn (Pfizer) – Capsule Damage (2014)

Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

Class IIModerate

FDADec 3, 2014Nationwide• Pfizer Inc.

Fentanyl Citrate Injection (Hospira) – Sterility Concerns (2014)

Lack of Assurance of Sterility; improperly crimped fliptop vials

Class IIModerate

FDADec 3, 2014Nationwide• Hospira Inc.

Adult Multi-Plus Vitamins (ReNew Life) – Undeclared Wheat Allergen (2014)

Labels indicate "no wheat" "no gluten" and the products contain gluten and wheat or a wheat related allergen.

Class IIModerate

FDADec 2, 2014AL, AK, AZ +48 more• ReNew Life Formulas, Inc.

Benzonatate Capsules (Zydus) – Wet Capsules (2014)

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

Class IIModerate

FDANov 26, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Dacarbazine Injection (Hospira) – Discoloration Issue (2014)

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

FDANov 25, 2014Nationwide• Hospira Inc.

Clinimix E Solution (Baxter) – Sterility Concerns (2014)

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Class IIModerate

FDANov 25, 2014Nationwide• Baxter Healthcare Corp.

HydrALAZINE Tablets (Par) – Foreign Substance (2014)

Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Class IIModerate

FDANov 24, 2014Nationwide• Par Pharmaceutical Inc.

Ginseng Kianpi Pil (One and Zen) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Class IIModerate

FDANov 20, 2014Nationwide• One and Zen

Mercaptopurine Tablets (American Health) – Dissolution Failure (2014)

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

Class IIModerate

FDANov 19, 2014Nationwide• American Health Packaging

5-HTP Extra Strength (Nutri-Dyn) – mislabeling (2014)

Nutri-Dyn has initiated a recall due to mislabeling. During production of CoQ-10, Lot #140186, one or more bottles were mistakenly labeled as 5-HTP Extra Strength.

FDANov 17, 2014AZ, CO, IN +10 more• Nutri-Dyn Midwest, Inc.

Duloxetine HCl (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Zoledronic Acid (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Povidone K-30 API (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Dantrolene Sodium API (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Hyoscine Butylbromide API (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Minoxidil (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Paroxetine HCl API (Attix Pharmaceuticals) – Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

Amitriptyline HCl Active Pharmaceutical Ingredient (Attix) - Penicillin Contamination (2014)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class IIModerate

FDANov 14, 2014Nationwide• Attix Pharmaceuticals

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