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Showing 9381–9400 of 14370 results

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Hydrochlorothiazide Tablets (Unichem) – Tablet Contamination (2015)

Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

Class IIModerate

FDAJul 30, 2015Nationwide• Unichem Pharmaceuticals Usa Inc

JBN Chocolate Mocha Confidence (Nutrition Resource) - undeclared milk (2015)

Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

Class IIModerate

FDAJul 30, 2015Nationwide

• Nutrition Resource Services, Inc.

JBN Cherry Crush Whey Isolate (Nutrition Resource) - undeclared milk (2015)

Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

Class IIModerate

FDAJul 30, 2015Nationwide• Nutrition Resource Services, Inc.

JBN Vanilla Cream Casein Protein (Nutrition Resource) - undeclared milk (2015)

Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

Class IIModerate

FDAJul 30, 2015Nationwide• Nutrition Resource Services, Inc.

Berry Delight Supplement (Nutrition Resource) – Undeclared Milk (2015)

Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk

Class IIModerate

FDAJul 30, 2015Nationwide• Nutrition Resource Services, Inc.

Lisinopril Tablets 20mg (Wockhardt) – Manufacturing Deviation (2015)

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Class IIModerate

FDAJul 29, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets 5mg (Wockhardt) – Manufacturing Deviation (2015)

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Class IIModerate

FDAJul 29, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets 40mg (Qualitest) – Dissolution Failure (2015)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2015Nationwide• Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Dexmethylphenidate HCl Extended-Release Capsules (Novartis) – Dissolution Specification Failure (...

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

FDAJul 28, 2015NJ• Novartis Pharmaceuticals Corp.

Major Loratadine Orally Disintegrating Tablets (Ohm Laboratories) – Superpotent Drug (2015)

Superpotent Drug: Out Of Specification (OOS) result for Assay.

FDAJul 28, 2015Nationwide• Ohm Laboratories, Inc.

Daytrana Methylphenidate Patch (Noven Pharmaceuticals) – Defective Delivery System (2015)

Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Class IIModerate

FDAJul 27, 2015Nationwide• Noven Pharmaceuticals, Inc.

Testosterone Pellet 110mg (Moses Lake Pharmacy) – sterility issue (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

Vitamin D3 Oil (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

Vitamin D3 Oil Injection (Moses Lake 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

Testosterone Pellet 80mg (Moses Lake 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

Folic Acid 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

Univasc (UCB) – dissolution testing failure (2015)

Failed Dissolution Testing: Failed 24 month dissolution testing.

Class IIModerate

FDAJul 24, 2015Nationwide• Ucb, Inc

Methionine/Choline/Inositol Injection (Moses Lake Pharmacy) – sterility issue (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/Hydroxocobalamin (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 112mg (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

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