Posts Tagged ‘drug recall’

Pfizer Inc. Effexor XR ® (venlafaxine HCl) Recall

Monday, March 24th, 2014

Pfizer Inc. is voluntarily recalling Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. A pharmacist had reported that a bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules. Although Pfizer did not receive any other reports of poor packaging, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line.

The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.

There is a very low probability that other bottles of Effexor XR contain a Tikosyn capsule, Pfizer has initiated this voluntary recall as a precaution.Effexor XR is a prescription antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder with or without agoraphobia. Tikosyn is a Class III cardiac antiarrhythmic drug. It is used to treat irregular heartbeats and to maintain normal rhythm.

This recall extends to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.

These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.

Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their pharmacies.

If you have suffered medical harm or any kind of injury from using Effexor XR, contact a personal injury lawyer for a free consultation.

Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET). Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Pain Free By Nature Reumofan Plus Recall

Friday, March 21st, 2014

“Reumofan Plus” Tablets produced by Pain Free By Nature have been voluntarily recalled due to undeclared pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries. Reumofan Plus, was recalled after the FDA discovered that the product packaging failed to indicate active pharmaceutical ingredients.

Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. Reumofan Plus was distributed nationwide through sales on www.painfreebynature.com.

If you have suffered medical harm or any kind of injury from using this product, contact a New York personal injury lawyer for a free consultation.

Purchasers of Reumofan Plus are urged to return all unopened bottles to; Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, KS, 67058. Refunds will be mailed immediately following processing. Consumers with questions may contact the company at (719) 235-8864, Monday thru Friday, between 10:00 a.m. and 2:00p.m. MST.

McNeil Recalls Concentrated MOTRIN Infants’ Drops Original Berry Flavor Due to Drowning Hazard

Monday, October 21st, 2013

The U.S. Food and Drug Administration, in accordance with McNeil Consumer Healthcare, announced on September 6, 2013 a voluntary recall of Concentrated MOTRIN Infants’ Drops Original Berry Flavor ½ fluid ounce bottles.

According to the safety notice, after releasing three lots of this type of Motrin into the market, tiny plastic particles (approximately 1 mm in size) were identified in a different product lot during manufacturing. It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in Concentrated MOTRIN® Infants’ Drops. This affected product line was not released to the market. Out of an abundance of caution, McNeil is voluntarily recalling the three lots of Concentrated MOTRIN® Infants’ Drops.

It is reported that about 200,000 bottles of Concentrated MOTRIN® Infants’ Drops were distributed in the United States. The UPC code of bottles is 300450524157. McNeil is asking retailers to remove the effected lots from store shelves, and is asking consumers to stop using and dispose of any product they may have that is included in this recall.

McNeil has worked with the third party to ensure that corrective measures are currently in place and are effective. The potential for adverse medical events related to the reason for this recall is not likely. Concentrated Infants’ MOTRIN® Drops Dye-Free Berry Flavor 1 fl. oz. is not included in this recall. Children’s or Adult MOTRIN® products are not included in this recall.