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Showing 1601–1620 of 3363 results

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Ciprofloxacin Dextrose Injection (Claris) – superpotent (2017)

Superpotent

Class IIILow

FDANov 6, 2017Nationwide• Claris Lifesciences Inc

Dexamethasone Sodium Phosphate 20 mg/5 mL (West-Ward) – impurity concerns (2017)

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Class IIILow

FDANov 6, 2017Nationwide• West-Ward Pharmaceuticals Corp.

Bupropion HCL Tablets (Mylan) – Impurity Specifications Failure (2017)

Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

Class IIILow

FDANov 3, 2017Nationwide• Mylan Pharmaceuticals Inc.

Premio Strawberry Pralinati – Undeclared Colors (2017)

Undeclared Allergen

Gourmet International Inc. is initiating a voluntary recall of cookie products due to undeclared colors.

Class IIILow

FDANov 2, 2017AL, CA, FL +11 more• Gourmet International Inc.

Meclizine Tablets (Jubilant Cadista) – Unapproved Marketing (2017)

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Class IIILow

FDAOct 30, 2017Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Doan's Pain Relief Cream (Dr. Reddy's) – Labeling Mismatch (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle

Class IIILow

FDAOct 30, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Lumigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAOct 19, 2017Nationwide• Allergan Sales, LLC

Combigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAOct 19, 2017Nationwide• Allergan Sales, LLC

Methylphenidate Tablets (Teva) – Dissolution Failure (2017)

Failed Dissolution Specifications: Low out of specification results for dissolution.

Class IIILow

FDAOct 17, 2017Nationwide• Teva Pharmaceuticals USA

Clofarabine Injection (Sanofi-Aventis) – Incorrect Packaging (2017)

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

Class IIILow

FDAOct 13, 2017Nationwide• Sanofi-Aventis U.S. LLC