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Showing 1381–1400 of 1639 results

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Infant Dextrose Injection (Hospira) – Particulate Matter (2017)

Presence of Particulate Matter: human hair found within an internal sample syringe.

FDAApr 21, 2017Nationwide• Hospira Inc.

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC

EpiPen (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Class IHigh

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

EpiPen Jr. (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

INOVA Easy Pad (Cipher Pharmaceuticals) – Subpotent Formulation (2016)

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

FDADec 6, 2016AZ, CO, OH• Cipher Pharmaceuticals US LLC

TriMix 10mcg Alternative (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Quad Mix Alternative (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Quad Mix (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Testosterone Blend (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

TriMix 20mcg (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Sermorelin Forte Plus (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

TriMix (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Sermorelin GT (Tri-Coast Pharmacy) – Sterility Problem (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Tri-Amino (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Slim Shot (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Testosterone Cypionate Zinc (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

BCAA 30ml (Tri-Coast Pharmacy) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Ultra Amino Blend (Tri-Coast Pharmacy) – sterility risk (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Nandrolone Decanoate (Tri-Coast Pharmacy) – sterility concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Sermorelin Forte (Tri-Coast Pharmacy) – sterility risk (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

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