Archive for July 8th, 2010
McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica
FOR IMMEDIATE RELEASE — Fort Washington, PA (July 8, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). The risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the January 15, 2010 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions, and information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
Source: U.S. Food & Drug Administration
| Product Name | Lot Number | UPC Code |
|---|---|---|
| BENADRYL® ALLERGY ULTRATAB™ | ||
| BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count | ABA567 | 312547170338 |
| BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count | ABA574 | 312547170338 |
| Children’s TYLENOL® Meltaways | ||
| CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM 30 count | ABA544 | 300450519306 |
| MOTRIN® IB | ||
| MOTRIN® IB CAPLET 24 count | ACA003 | 300450481030 |
| MOTRIN® IB CAPLET bonus pack 50+25 count | ACA002 | 300450481764 |
| MOTRIN® IB TABLET 100 count | AFA060 | 300450463043 |
| TYLENOL®, Extra Strength | ||
| TYLENOL®, Extra Strength EZ TABLET 225 count | ASA206 | 300450422378 |
| TYLENOL®, Extra Strength EZ TABLET 50 count | ABA005 | 300450422507 |
| TYLENOL®, Extra Strength COOL CAPLET 24 count | ABA566 | 300450444240 |
| TYLENOL®, Extra Strength CAPLET bonus pack 24+12 count | ACA025 | 300450444318 |
| TYLENOL®, Extra Strength CAPLET 50 count | AFA018 | 300450449078 |
| TYLENOL®, Extra Strength CAPLET 50 count
(included in Day/Night Pack) |
ABA168 | 300450444530 |
| TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) |
AEC005 | 300450527103 |
| TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) |
AFC005 | 300450527103 |
| TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530) |
ADC002 | 300450527103 |
| TYLENOL®, Extra Strength RAPID RELEASE GELCAP 24 count | ACA024 | 300450488244 |
| TYLENOL®, Extra Strength RAPID RELEASE GELCAP 225 count | AJA119 | 300450488251 |
| TYLENOL® PM | ||
| TYLENOL® PM CAPLET 24 count | ACA005 | 300450482242 |
| TYLENOL® PM CAPLET 24 count | ADA259 | 300450482242 |
| TYLENOL® PM GELTAB 50 count | AFA100 | 300450176509 |
| TYLENOL® PM RAPID RELEASE GELCAP 20 count | ACA004 | 300450244208 |
Ready Pac Foods, Inc. Announces Voluntary Product Recall because of Possible Health Risk
FOR IMMEDIATE RELEASE – July 07, 2010 – Ready Pac Foods, Inc. Irwindale, CA is recalling 702 cases of the Baby Spinach variety of Spinach Temptations 6 oz. bagged salads with Useby Dates of July 4 with Product Code 11707B, IR127121 and July 8 with Product Code 12007B, IR130373 because they could be contaminated by Escherichia coli 0157:H7 (Ecoli 0157.H7). The recall extends only to products with this Use-by Date or Product Code sold in the following states: California, Washington and Arizona. No other Ready Pac Foods, Inc. products are included in the recall.
No illnesses related to these products have been reported.
Ready Pac is collaborating closely with the FDA. The recall notification is being issued out of an abundance of caution based on a confirmed positive result for Ecoli 0157:H7 in a random sample test conducted by the FDA.
Ecoli 0157:H7 is an organism that may cause diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
Because it is still possible that products bearing the Use-by Dates of July 4 and July 8 with the above Products Codes could be on store shelves, this recall extends to retailers as well as consumers. Ready Pac believes that it is important to alert consumers and retailers who might still possess one of the potentially affected salads to dispose of it immediately.
Ready Pac Foods, Inc. has earned an outstanding safety record for over 40 years and has taken immediate precautionary measures to protect public health by issuing this voluntary recall and removing product from the market. We have notified all of our retail customers who have received the product in question and directed them to remove it from their shelves.
Instructions for Consumers:
Check your refrigerator for Ready Pac Baby Spinach, Spinach Temptations 6 oz. bagged salads with the Use-by Dates of July 4 and July 8 with the above Products Codes. The Use-by Dates are found in the upper left hand corner of the package with the Product Codes located immediately underneath.
Consumers who may have purchased the affected product are asked to record the Use-by Date and Product Code, immediately dispose of the product, and contact the Ready Pac Consumer Affairs representative, toll-free at (800) 8007822, Monday – Friday, 8 a.m. to 5 p.m. (Pacific Time) to obtain a full refund.
Instructions for Retailers:
All retailers who receive this product are asked to reconfirm with their distribution centers and all individual stores to ensure that no Baby Spinach with the Code Dates of July 4 and July 8 with the above Product Codes remains in their inventory or at store locations. A separate notification will be forwarded to all relevant Ready Pac retail customers. For additional details, retailers are asked to contact their Ready Pac customer service representative.
Complete Listing of Recalled Ready Pac Spinach Salad Products, Use-by Dates and Product Codes as follows:
Ready Pac Baby Spinach, Spinach Temptations 6 oz bagged salads (UPC Code 77745 20676) with the
following Product Codes and Use-by Dates:
BEST IF USED BY: July 4th
11707B
IR127121
BEST IF USED BY: July 8th
12007B
IR130373
Source: U.S. Food & Drug Administration