Recalls/Warnings/Notices
Medication & Medical Supply Recalls
FDA Requires Boxed Warning and Risk Mitigation Strategy for metoclopramide/Reglan Containing Drugs.
Agency warns against chronic use of these products to treat gastrointestinal disorders. Please go to the FDA
Website to read about this important warning!
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements

Second Safety Warning on Fentanyl Skin Pain Patch
Please go to the FDA Website to read about this important warning!
www.fda.gov/ForConsumers/ConsumerUpdates

Flagyl (metronidazole) 500 mg I.V. injection RTU (in plastic container)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  
August 2009 - With oral metronidazole: Central Nervous System: Encephalopathy, aseptic meningitis, optic
neuropathy, dysarthria.
Hypersensitivity:..Stevens-Johnson Syndrome.
www.fda.gov/Safety/MedWatch/SafetyInformation
Here is some added information on Metronidazole: dosage, concerns, uses, positives, etc.
www.marvistavet.com/html/body_metronidazole

Flagyl (metronidazole) tablets, capsules, and Flagyl ER tablets
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010 -
New warnings and adverse reactions
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225998.htm

Sandimmune (cyclosporine) soft gelatin capsules, injection, and oral solution. Can be used for cats with
autoimmune diseases.
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm212122.htm

Evamist Hormone Spray May Cause Illness in Pets
Topical hormone spray for women can cause serious health risks if pets come in contact.
www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm220420.htm

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change.
Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory
depression and death.
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm

Possible Increased Risk of Bone Fractures with Prevacid and Prilosec.
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm228392.htm

FDA’s Center for Veterinary Medicine Alerts Veterinarians About Problems with Vetsulin® to Treat Diabetes in
Dogs and Cats.
www.fda.gov/AnimalVeterinary/newsEvents/CVMUpdates/ucm188752.htm

FDA Announces Addition of Boxed Warning to METACAM® (meloxicam) Labels
www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm231254.htm

Gris-PEG (griseofulvin ultramicrosized) tablets (used for ringworm)
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm232426.htm

Lasix (commonly used for congestive heart failure in cats)
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm232345.htm

Cardizem CD (diltiazem hydrochloride) Capsules and Tablets, Cardizem LA (diltiazem hydrochloride)
Extended-Release Tablets (used for HCM)
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm235555.htm

Reglan (metoclopramide) tablets, ODT (Orally Disintegrating Tablets), and injection
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm170934.htm

Anzemet (dolasetron mesylate): Drug Safety Communication -
Reports of Abnormal Heart Rhythms
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237341.htm

Zithromax (azithromycin) tablet, single-dose packet, IV for injection, and oral suspension
WARNINGS OF Hepatotoxicity/Abnormal liver function
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm262866.htm
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm?
source=govdelivery

Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated
With Long-Term Use: Pepcid/famotidine and/or Zantac/ranitidine are NOT PPIs so there’s no need to worry
about using those. This is for all the ones listed on the FDA page (link provided). Magnesium isn't usually
measured on routine labs so you can't count on it showing up if your kitty gets regular chem profiles - if anyone is
using a PPI long-term, your vet may want to check those levels when getting your cat’s labs done.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm

FDA Warns of Possible Danger with Animal Vaccine Device
The Food and Drug Administration is warning veterinarians and pet owners, particularly cat owners, of the
possible risk of fractures with the Vet Jet™ transdermal vaccination system device.
www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm270642.htm

Counterfeit Pesticide Products for Dogs and Cats
Information for consumers about counterfeit topical flea & tick treatments for dogs and cats
www.epa.gov/opp00001/factsheets/petproduct.htm

Plavix (clopidogrel bisulfate) tablet Safety label change
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225843.htm

Levemir (insulin detemir [rDNA origin] injection)
www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121357.htm

Sporanox (Itraconazole) Capsules
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm303524.htm

Biaxin Filmtab (clarithromycin tablets, USP), Biaxin XL Filmtab (clarithromycin extended-release
tablets), Biaxin Granules (clarithromycin for oral suspension, USP)
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm258816.htm

Lotensin/benazepril
www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm323785.htm

Carafate (sucralfate) Tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm346722.htm
Carafate (sucralfate) suspension
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm239763.htm
Insulin Product Labeling Changes March 2013
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm347720.htm

Lamisil (terbinafine hydrochloride) Tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm360349.htm
Lamisil (terbinafine hydrochloride) Oral Granules
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm360355.htm
Urso and Urso Forte (ursodiol) tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm360280.htm

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve
damage.
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by
injection.  Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin
(Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). Some other Fluoroquinolone drugs
not included in this list are Baytril and Orbax but are worth taking this warning into consideration for those as well.
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365302.htm?
source=govdelivery

Prozac (fluoxetine hydrochloride) Delayed Release Capsules
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm364458.htm

Duragesic (fentanyl) Patches: Drug Safety Communication
Packaging Changes to Minimize Risk of Accidental Exposure
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369457.htm?
source=govdelivery&utm_medium=email&utm_source=govdelivery

Septra and Septra DS (Trimethoprim and Sulfamethoxazole) Tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm370057.htm
Biaxin Filmtab (clarithromycin tablets, USP), Biaxin XL Filmtab (clarithromycin extended-release
tablets), Biaxin Granules (clarithromycin for oral suspension, USP)
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm258816.htm
Plavix (clopidogrel bisulfate) tablet
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225843.htm

Lantus (insulin glargine [rDNA origin] injection) solution
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm373727.htm
Glucovance (glyburide and metformin HCl) tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194334.htm
Glucotrol and Glucotrol XL (glipizide) tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm181152.htm

Zofran (ondansetron hydrochloride) tablets, oral solution, orally disintegrating tablet, and injection
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm230231.htm

Neurontin (gabapentin)
www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm154552.htm
Tenormin (atenolol) Tablets www.fda.gov/Safety/MedWatch/SafetyInformation/ucm271111.htm

Imuran (azathioprine) Tablets and Injection
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm258794.htm
Pepcid (famotidine) tablets
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm207452.htm

Azulfidine (Sulfasalazine) Tablets, USP and Azulfidine EN-Tabs
(Sulfasalazine Delayed Release) Tablets, USP
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm335424.htm
Diflucan (fluconazole) tablets, I.V, and oral suspension
www.fda.gov/Safety/MedWatch/SafetyInformation/ucm262570.htm
Food Recalls & Notices
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report
False Results
Posted April 29, 2014
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm?sourc
e=govdelivery&utm_medium=email&utm_source=govdelivery
Medication/Medical Supply Warnings, Safety Label Changes
PMI Nutrition, LLC Recalls Red Flannel® Cat Food Due to Possible Salmonella Contamination
Posted January 27, 2014
www.fda.gov/Safety/Recalls/ucm383066.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Pro-Pet LLC Recalls a Limited Number of Dry Dog and Cat Foods Due to Possible Salmonella
Contamination
Posted Feb. 7, 2014
www.fda.gov/Safety/Recalls/ucm384876.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

The formula being recalled is for CATS
The Robert Abady Dog Food Co., LLC RECALLS "Abady Highest Quality Maintenance & Growth
Formula for Cats" BECAUSE OF POSSIBLE HEALTH RISK.
Posted April 10, 2014
www.fda.gov/Safety/Recalls/ucm392618.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Bravo® Issues Nationwide Recall of Pet Food for Dogs and Cats Posted May 14, 2014
www.fda.gov/Safety/Recalls/ucm397362.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Pet Center, Inc. Voluntary Recall of 3 oz bag of Lamb Crunchy’s Because of Possible Health Risk
Posted May 27, 2014
www.fda.gov/Safety/Recalls/ucm399087.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Hill’s Pet Nutrition, Inc. Voluntarily Recalls 62 Bags of “Science Diet® Adult Small & Toy Breed™” Dry
Dog Food in California, Hawaii and Nevada Because of Potential Health Risk
Posted June 3, 2014
www.fda.gov/Safety/Recalls/ucm399662.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
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