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Showing 8721–8740 of 14454 results

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Tobramycin NS Accuflo (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

Invanz (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

Clindamycin (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

Pedi MVI Syringe (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

TPN Formula Bag (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

Meropenem (Walgreens) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDANov 10, 2015TX• Walgreens Infusion Services

Baclofen USP Powder (Freedom Pharmaceuticals) – Foreign Substance (2015)

Presence of Foreign Substance

Class IIModerate

FDANov 9, 2015Nationwide• Freedom Pharmaceuticals Inc

Vitamin D3 Supplement (Glades Drugs) – Superpotent Drug (2015)

Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

FDANov 6, 2015GA, NY• Glades Drugs Inc.

Kroger Apple Juice (Kroger) – Patulin Levels (2015)

The firm received notification from the Alabama Dept. of Agriculture that a test came back indicating the levels of patulin was three times over the legal limit for patulin in two code dates of the Kroger Natural Apple Juice.

Class IIModerate

FDANov 5, 2015AL, AZ, AR +23 more• The Kroger Co

Bevacizumab Intravitreal Syringe (Pine Pharmaceuticals) – Silicone Microdroplets (2015)

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Class IIModerate

FDANov 4, 2015Nationwide• Pine Pharmaceuticals, LLC

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Bevacizumab Intravitreal Syringe (Pine Pharmaceuticals) – Silicone Microdroplets (2015)

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Class IIModerate

FDANov 4, 2015Nationwide• Pine Pharmaceuticals, LLC

Bevacizumab Intravitreal Syringe (Pine Pharmaceuticals) – Silicone Microdroplets (2015)

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Class IIModerate

FDANov 4, 2015Nationwide• Pine Pharmaceuticals, LLC

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Bevacizumab Intravitreal Syringe (Pine Pharmaceuticals) – Silicone Microdroplets (2015)

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Class IIModerate

FDANov 4, 2015Nationwide• Pine Pharmaceuticals, LLC

Meclizine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

FDANov 2, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Hydrochlorothiazide Capsules (Amerisource) – Particulate Matter (2015)

Presence of Particulate Matter

Class IIModerate

FDAOct 29, 2015Nationwide• Amerisource Health Services

Epsom Salt (PQ Corporation) – Iron Impurity (2015)

Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).

FDAOct 29, 2015KY• PQ Corporation

Auvi-Q Epinephrine (Sanofi) – Dosage Delivery Issue (2015)

Defective Delivery System; potential to have inaccurate dosage delivery

FDAOct 28, 2015Nationwide• Sanofi-Aventis U.S. LLC

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