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Showing 9481–9500 of 14370 results

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Trimix Injectable 20mg/1mg/20mcg (Moses Lake Professional Pharmacy) – sterility risk (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Nisoldipine Extended Release 17mg (Shionogi) – dissolution failure (2015)

Failed Dissolution Specifications

FDAJul 24, 2015Nationwide• Shionogi Inc.

Combivent Respimat (Boehringer Ingelheim) – defective delivery system (2015)

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

Class IIModerate

FDAJul 24, 2015Nationwide• Boehringer Ingelheim Roxane Inc

Alprostadil Injectable Solution (Moses Lake Pharmacy) – sterility concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

B Vitamin Injectable Solution (Moses Lake Pharmacy) – Sterility Concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Methylcobalamin MDV Injection (Moses Lake Pharmacy) – sterility concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Sermorelin/GHRP Injectable (Moses Lake Professional Pharmacy) – sterility risk (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Methylcobalamin Injectable Solution (Moses Lake Pharmacy) – Sterility Concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Methylcobalamin Injection (Moses Lake Pharmacy) – sterility concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Glutathione Injectable Solution (Moses Lake Pharmacy) – sterility concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Testosterone Pellet (Moses Lake Pharmacy) – sterility concern (2015)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class IIModerate

FDAJul 24, 2015Nationwide• JD & SN Inc., dba Moses Lake Professional Pharmacy

Verapamil Extended-Release 240mg (Apotex) – dissolution failure (2015)

Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.

FDAJul 21, 2015Nationwide• Apotex Inc.

Phentermine Capsules 15mg (PD-Rx) – impurity specification (2015)

Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station

FDAJul 21, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Ropivacaine HCl 0.2% Injectable (Pharmedium) – sterility failure (2015)

Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.

Class IIModerate

FDAJul 21, 2015ID, IL, PA +1 more• Pharmedium Services, LLC

Allopurinol Tablets 300mg (Qualitest) – tablet specification issue (2015)

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

FDAJul 20, 2015Nationwide• Qualitest Pharmaceuticals

Glycopyrrolate 0.2 mg (Pharmedium) – Potency Loss (2015)

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

HYDROmorphone HCl 0.2 mg (Pharmedium) – Potency Loss (2015)

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Sodium Chloride Injection (Baxter) – insect contamination (2015)

Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.

FDAJul 17, 2015Nationwide• Baxter Healthcare Corp.

Fentanyl Citrate (Pharmedium) – Potency Loss (2015)

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Morphine Sulfate (Pharmedium) – Potency Loss (2015)

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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