2014 Product Recalls

Brake Line Corrosion at Four-Way Connector

Brake fluid may leak due to the brake line corrosion and may result in longer distances being required to slow or stop the vehicle, increasing the risk of a crash.

Subaru will notify owners, and dealers will apply an anti-corrosion wax to the four-way joint connector area of the brake line system, free of charge. The recall began on January 27, 2015. Owners may contact Subaru customer service at 1-800-782-2783. Subaru's number for this recall is WQQ-52. Notes: This recall is specific to affected Forester, Impreza, WRX, and STI customers who had their car remedied under NHTSA recall no. 14V-311 prior to December 23, 2014. Subaru has determined that this remedy was inadequate due to incomplete repair instructions provided to dealers. Affected Forester, Impreza, WRX, and STI vehicles that were not repaired under NHTSA recall no. 14V-311 prior to December 23, 2014 will continue to be processed under NHTSA recall no. 14V-311. Affected vehicles not currently, or formerly, registered in the salt belt states identified in this recall are eligible for repair, at no cost to the customer, upon request.

Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical

Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.

Focus Diagnostics sent an Urgent Safety Notice Correction letter dated May 15, 2014, to all affected customers. The notification, informed customers of the product, the problem, and the action to be taken by the customer. To decrease the likelihood of obtaining any false results caused by either manually entering a spectral matrix or storing the DAD improperly after each use, please follow the recommended warnings and precautions provided in the revised and attached Simplexa Flu A/B & RSV Direct (PI.MOL2650 Rev. D) package insert. 1. The spectral matrix must be installed in each 3M Integrated Cycler and should not be changed unless an updated QR code for the instrument is provided by Focus Diagnostics. The spectral matrix is unique to each 3M Integrated Cycler. The spectral matrix was provided with the 3M Integrated Cycler instrument on the cover of the 3M Integrated Cycler Hardware Manual. If the matrix label will not scan or cannot be found, contact Focus Diagnostics. The contact information is on the last page of this document. 2. Not installing or changing the spectral matrix can result in false results. 3. After each use store DAD discs flat with the numbered foil side up. Customers were instructed to acknowledge that they have received this notification by signing the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at 562-240-6526 within 10 business days. The Notice of Correction and Acknowledgement Form was sent to customers on 05/15/2014 via email and USPS mail. Additional customers were notified on 05/29/2014 via email and USPS mail. For questions regarding this recall call 714-220-1900.

Private Selection Extreme Moose Tracks Ice Cream; packaged in plastic 48 fl oz containers, UPC Code: 11110-00456

The ice cream product may contain peanuts not listed on the ingredient statement.

Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9

Tricar is recalling Organic English Cucumbers because they may be contaminated with E.coli.

HyVee Cheddar Cheese Stuffed Jalapenos. Product is breaded jalapeno stuffed with cheddar cheese designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 ounces, and packed 12 units per case. The UPC is 0 75450 14989 0. The product is labeled in parts: "***HyVee cheddar cheese stuffed jalapenos***jalapenos stuffed with cheddar cheese in a crispy breading***ovenable k

HyVee Cheddar Cheese Stuffed Jalapenos is recalled due to undeclared egg.

Whole Foods Tarte Aux Pomme 10 inch, packaged in a brown box. Net Wt. 2 lb 8 oz. UPC: 23072300000

Product contains undeclared almonds

Shelled Peanuts, in bulk

One lot of raw peanuts was found to contain 26 ppb Aflatoxin

White Tahina, Net Wt. 907 g, 12 jars/case

Zacares USA is recalling White Tahina because it may be contaminated with Salmonella.

Willy's Just Peachy Salsa, packaged in 16-oz. plastic deli containers

The firm did not list food color, FD & C yellow #5, on the label.

Pea River Raw Shelled Raw Fine Alabama Grown Peanuts, Net Wt. 2.5 lbs

Product testing at the supplier found aflatoxin above 20 ppb

Coca Cola Zero, 2 liter pet bottle, UPC 49000 05014, The Coca Cola Company

Equipment malfunction led to ingredients to be blended at levels that are inconsistent with approved formulations.

Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pom

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03

Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6; d) exact, Prepared For/Prepare Pour: Loblaws Inc., Montreal H4N 3L4, Tonronto M4T 2S8, Calgary T2E 7S9, CANADA, Impor

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.