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Showing 11361–11380 of 14370 results

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

Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Class IIModerate

FDAJun 27, 2014Nationwide• Hospira Inc.

Fentanyl Prefilled Syringe (Healix) – Sterility Concern (2014)

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Class IIModerate

FDAJun 27, 2014GA, TX• Healix Infusion Therapy, Inc.

Fentanyl Prefilled Syringe (Healix) – Sterility Concern (2014)

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Class IIModerate

FDAJun 27, 2014GA, TX• Healix Infusion Therapy, Inc.

Fentanyl Ropivacaine Injection (Healix) – Sterility Concern (2014)

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Class IIModerate

FDAJun 27, 2014GA, TX• Healix Infusion Therapy, Inc.

Fentanyl Sodium Chloride Bag (Healix) – Sterility Concern (2014)

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Class IIModerate

FDAJun 27, 2014GA, TX• Healix Infusion Therapy, Inc.

Cephalexin Capsules 500mg (Caraco) – Manufacturing Deviation (2014)

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Class IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Lortuss EX Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

FDAJun 26, 2014Nationwide• Poly Pharmaceuticals, Inc

Cephalexin Capsules 250mg (Caraco) – Manufacturing Deviation (2014)

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Class IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Poly-Tussin AC Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

FDAJun 26, 2014Nationwide• Poly Pharmaceuticals, Inc

Vitamin B12 Methylcobalamin 5000 Injection (Medical Supply Liquidators) – Unapproved Manufacturin...

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Glutathione Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

L-Carnitine Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Super MIC B Complex Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Vitamin B6 Pyridoxine HCL Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

B Complex Injection (Medical Supply) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Lipo 8 Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

G.A.C. 375 Injection (Medical Supply Liquidators) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

BCAA 4% Injection (Medical Supply) – Unapproved Manufacturing (2014)

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Vitamin B12 Cyanocobalamin MIC Injection (Medical Supply Liquidators) – Unapproved Manufacturing ...

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

Vitamin B12 Methylcobalamin MIC Injection (Medical Supply Liquidators) – Unapproved Manufacturing...

Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer

Class IIModerate

FDAJun 25, 2014Nationwide• Medical Supply Liquidators Llc

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