Nostrilla Nasal Decongestant: Recall - Bacterial Contamination

AUDIENCE: Consumer, Pharmacy

ISSUE: Insight Pharmaceuticals, LLC recalled one lot (lot #11G075, UPC Code 6373673005, 34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia. Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis).

BACKGROUND: Nostrilla Nasal Decongestant was distributed nationwide through normal retail outlets and pharmacies. The product comes in a 1/2 ounce, plastic bottle marked with an expiration date of 05/2014 stamped on the...

 In full cooperation with the United States Food and Drug Administration, CooperVision, Inc. is continuing to work with the FDA, distributors, customers, eye care practitioners and lens wearers to complete the worldwide recall initiated on August 19, 2011 on certain lots of Avaira™ Toric contact lenses.

“Our first priority is always the health and safety of all CooperVision lens wearers and as such we responded quickly to complaints from our customers by initiating a voluntary recall” said Christine Moench, vice president, Global Regulatory Affairs and Quality Assurance. “We want to ensure that all consumers are aware of this action and know where to go for more information.”

If you wear Avaira Toric...

CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses

AUDIENCE: Eye Care, Consumers

ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses.  Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.  
BACKGROUND:  Used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.  The...

Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

AUDIENCE: Hematology, Oncology

ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug...

Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid

AUDIENCE: Consumer

ISSUE: FDA notified the manufacturer that lab analyses found that the product, sold as a testosterone booster, contains superdrol, a synthetic steroid, making it an unapproved new drug. Acute liver injury is known to be a possible harmful effect of using products containing synthetic anabolic steroids. In addition, use of synthetic anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse...

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error

includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, Tri-Previfem

AUDIENCE: Consumer, Pharmacy, OB/GYN

ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being  incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer...

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections...