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Showing 8741–8760 of 14454 results

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Auvi-Q Epinephrine (Sanofi) – Dosage Delivery Issue (2015)

Defective Delivery System; potential to have inaccurate dosage delivery

FDAOct 28, 2015Nationwide• Sanofi-Aventis U.S. LLC

Cookies 'n' Cream Fruit Bars (Helados La Tapatia) – Undeclared Eggs (2015)

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..

FDAOct 27, 2015AZ, CA, NV +1 more• Helados La Tapatia, Inc.

HiCort Suppositories (Geritrex) – Unapproved Drug (2015)

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Class IIModerate

FDAOct 27, 2015Nationwide• Geritrex Corp

Carbo-O-Philic Gel (Geritrex) – Unapproved Drug (2015)

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Class IIModerate

FDAOct 27, 2015Nationwide• Geritrex Corp

Carbo-O-Philic Cream (Geritrex) – Unapproved Drug (2015)

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Class IIModerate

FDAOct 27, 2015Nationwide• Geritrex Corp

Meclizine Hydrochloride Tablets (Par Pharmaceutical) – impurity specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

FDAOct 26, 2015Nationwide• Par Pharmaceutical Inc.

Meclizine Hydrochloride Tablets (Par Pharmaceutical) – impurity specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

FDAOct 26, 2015Nationwide• Par Pharmaceutical Inc.

Ranitidine Syrup (Qualitest) – preservative specification (2015)

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

FDAOct 21, 2015Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Duloxetine Capsules (Breckenridge) – foreign capsule found (2015)

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

FDAOct 21, 2015Nationwide• Breckenridge Pharmaceutical, Inc

Irbesartan Hydrochlorothiazide (Teva) – incorrect labeling (2015)

Labeling: Incorrect or Missing Lot AND/OR Exp Date.

FDAOct 20, 2015Nationwide• Teva Pharmaceutical Industries

PZI 40 Insulin Injection (Western Drug) – sterility concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Lidocaine Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Vitamin B-Complex 100 Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Vitamin B12 Injection (Western Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 19, 2015Nationwide• Western Drug

Acetyl-L-Carnitine Injectable (Downing Labs) – Sterility Risk (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

Cyanocobalamin Buffered Injectable (Downing Labs) – Sterility Risk (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

Magnesium Chloride Injection (Downing Labs) – Sterility Concern (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

L-Arginine Injection (Downing Labs) – Sterility Risk (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

Magnesium Sulfate Injectable (Downing Labs) – Sterility Risk (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

Procaine Injectables (Downing Labs) – Sterility Risk (2015)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 16, 2015Nationwide• Downing Labs, LLC

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