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Showing 11721–11740 of 14370 results

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Lidocaine HCl Injection (Hospira) – Particulate Matter (2013)

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

FDADec 23, 2013Nationwide• Hospira Inc.

Diclofenac Sodium Tablets (Watson) – Tablet Split Issue (2013)

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Class IIModerate

FDADec 20, 2013Nationwide• Watson Laboratories, Inc.-(Actavis) - Florida

MINERAL IV Injection (Abrams Royal) – Non-Sterility (2013)

Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis

FDADec 19, 2013Nationwide• Abrams Royal Pharamacy

Sterile Drug Products (Abrams Royal) – Sterility Concern (2013)

Lack of Assurance of Sterility

Class IIModerate

FDADec 19, 2013Nationwide• Abrams Royal Pharamacy

Hydralazine HCL 25mg Tablets (Teva) – Impurity Risk (2013)

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

Class IIModerate

FDADec 18, 2013Nationwide• Teva Pharmaceuticals USA

Hydralazine HCL 50mg Tablets (Teva) – Impurity Risk (2013)

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

Class IIModerate

FDADec 18, 2013Nationwide• Teva Pharmaceuticals USA

VoLumen Barium Suspension (Bracco) – Preservative Issue (2013)

Failed Stability Testing: This product is below specification for preservative content.

FDADec 16, 2013Nationwide• Bracco Diagnostics Inc

Cetirizine Hydrochloride Syrup (Qualitest) – Impurity Found (2013)

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

FDADec 16, 2013Nationwide• Qualitest Pharmaceuticals

Metoprolol Succinate Tablets (Dr. Reddy's) – Dissolution Issue (2013)

Failed Dissolution Specification; 12-Month stability interval.

Class IIModerate

FDADec 13, 2013LA, MI, MS +2 more• Dr. Reddy's Laboratories, Inc.

Pyridostigmine Bromide Tablets (Corepharma) – Dissolution Fail (2013)

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Class IIModerate

FDADec 13, 2013Nationwide• Corepharma LLC

Bupivacaine Solution (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

Oxytocin Sodium Chloride Bags (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

Vitamin B-12 Injections (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

Magnesium Sulfate Bags (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

Propofol Injection (Hospira) – Glass Defect (2013)

Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.

Class IIModerate

FDADec 12, 2013Nationwide• Hospira Inc.

Sodium Bicarbonate 8.4% (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

Potassium Phosphates Vials (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Class IIModerate

FDADec 12, 2013AZ• Zions RX Formulations Services LLC dba RX Formuations Serv.

HydrOXYzine HCI Tablets 50mg (KVK-Tech) – Unapproved Ingredient (2013)

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Class IIModerate

FDADec 11, 2013Nationwide• KVK-Tech, Inc.

HydrOXYzine HCI Tablets 10mg (KVK-Tech) – Unapproved Ingredient (2013)

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Class IIModerate

FDADec 11, 2013Nationwide• KVK-Tech, Inc.

HydrOXYzine HCI Tablets 25mg (KVK-Tech) – Unapproved Ingredient (2013)

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Class IIModerate

FDADec 11, 2013Nationwide• KVK-Tech, Inc.

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