Schindele Enterprises dba Midwest Wholesale Recalls

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

BOOST ULTRA – Undeclared Drug Ingredient (2014)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

XZONE GOLD – Undeclared Drug Ingredient (2014)

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Undeclared Allergen

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Class IHigh

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

Magic For Men – Undeclared Drug Ingredient (2014)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

Gas-Fired Boilers (U.S. Boiler) – Carbon Monoxide Risk (2014)

Fire/Burn Risk

This recall involves U.S. Boiler ESC, PVG and SCG model cast iron hot water boilers that use natural gas or liquid petroleum to heat water for residential space heating. The boilers are light blue in color with black trim, about 40 inches tall, about 26 inches deep and range from 12 to 31 inches wide. The model name and U.S. Boiler logo are on the front cover of the boiler. The front cover of the boiler is vented. Recalled boilers were manufactured between December 2005 and February 2013. The model number, serial number and manufacturing date are located on a silver label on the top panel of ESC models and on the inside of PVG and SCG models on the right side panel. The manufacturing date appears in the upper right corner of the silver label in the MM/YYYY format. The following model numbers and serial number ranges are included in this recall: Model Number Serial Number Range ESC3 through ESC9 65249110 through 65382278 PVG3_P, PVG4_P and PVG5 through PVG9 64870666 through 65385748; 97939433 SCG3 through SCG9 35200197; 65283322 through 65858729

CPSCJan 9, 2014Nationwide• U.S. Boiler Company Inc., of Lancaster, Penn.

Olympic Decline Bench (Cybex) – Fall Injury Hazard (2014)

The Decline model free weight benches are designed for use in professional gyms and come in three model numbers: 16060, 16061 and 16062. The Decline model free weight bench is a traditional Olympic bench which accommodates a 7' wide Olympic bar, and the back pad declines from the knee to the shoulders at a 15 degree angle. The model numbers can be found on the bottom of the tube near where the feet are placed with serial numbers C1208 through H0913 which stand for the manufacture dates, December 2008 through September 2013.

CPSCJan 9, 2014Nationwide• Cybex International, Inc., of Medway, Mass.

ExtenZe – Undeclared Drug Ingredient (2014)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

XZEN PLATINUM – Undeclared Drug Ingredient (2014)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

MiracleZEN Platinum – Undeclared Drug Ingredient (2014)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

FDAJan 9, 2014CA, CT, FL +10 more• Schindele Enterprises dba Midwest Wholesale

Lansoprazole Capsules (Dr. Reddy's) – Microbial Contamination (2014)

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.

FDAJan 3, 2014Nationwide• Dr. Reddy's Laboratories, Inc.

Carisoprodol Tablets (Watson Laboratories) – Metal Particulates (2013)

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

FDADec 23, 2013Nationwide• Watson Laboratories Inc

Diclofenac Sodium Tablets (Watson) – Tablet Split Issue (2013)

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

FDADec 20, 2013Nationwide• Watson Laboratories, Inc.-(Actavis) - Florida

Tabouli Salad (Good Neighbors) – Foreign Object (2013)

Customer found blade inside the salad.

FDADec 19, 2013CT, ME, MA +3 more• Good Neighbors Specialty Foods, LLC

Thickened Water Pudding (Nutra Balance) – Mold Contamination (2013)

NUTRA Balance Pre-Thickened Water was found to contain mold.

FDADec 19, 2013CA, IN, MN +4 more• Nutra Balance Products

Thickened Water Nectar (Nutra Balance) – Mold Contamination (2013)

NUTRA Balance Thickened Water Nectar Thick was found by the FDA to contain mold. In addition, Thickened Water Pudding thick was sampled by Nutra Balance Products and it subsequently tested positive for Enterobacter sp. and Xanthomonas sp.

FDADec 19, 2013CA, IN, MN +4 more• Nutra Balance Products

Bristol Valley Cocktail Glasses (Libbey) – Laceration Risk (2013)

Laceration Risk

This recall involves Bristol Valley, model 8555SR, cocktail glasses with sheer rims. The glasses are made of clear, colorless glass in a 7.75-ounce cocktail design with a thin rim. The glasses measure about 6¼ inches high, 3¼ inches wide at the base, and 4¼ inches wide at the top. They were sold individually and in 24-piece cartons for commercial users.

CPSCDec 18, 2013Nationwide• Libbey Glass Inc., of Toledo, Ohio

VoLumen Barium Suspension (Bracco) – Preservative Issue (2013)

Failed Stability Testing: This product is below specification for preservative content.

Class IIILow

FDADec 16, 2013Nationwide• Bracco Diagnostics Inc

Curl Activator Gel (Long Aid) – Cloudy Appearance (2013)

Product has a cloudy appearance

Class IIILow

FDADec 13, 2013CA, CT, FL +7 more• Keystone Laboratories Inc

Metoprolol Succinate Tablets (Dr. Reddy's) – Dissolution Issue (2013)

Failed Dissolution Specification; 12-Month stability interval.

FDADec 13, 2013LA, MI, MS +2 more• Dr. Reddy's Laboratories, Inc.

Vitamin B-12 Injections (Zions RX) – Sterility Concern (2013)

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.