Health > Recalls

Recalls - Plastic Particles

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Mimi:
Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 
McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of
Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz.

Contact
Consumer:
1-877-414-7709
 

FOR IMMEDIATE RELEASE - September 6, 2013 - McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). McNeil is asking retailers to remove the affected 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.

FULL RECALLED PRODUCT LIST:
Product    Lot #    UPC Code    Case UPC Code
Concentrated MOTRIN® Infants’ Drops
Original Berry Flavor 1/2 fl oz bottles

NDC 50580-100-18    DCB3T01    300450524157    30300450524158
DDB4R01
DDB4S01

After releasing these three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing. This lot was not released to the market. 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 Original Berry Flavor 1/2 fl oz. Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. 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.

Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

    Online: www.fda.gov/medwatch/report.htm
    Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
    Fax: 1-800-FDA-0178.

Mimi:
Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 
General Mills Announces Voluntary Recall of Limited Quantity of Refrigerated Pillsbury Cinnamon Rolls With Icing

 
No Other Flavors or Varieties of Pillsbury Cinnamon Rolls are Involved

 

Contact:
Consumer:
1-800-775-4777

Media:
Mike Siemienas
763-764-6364
 

FOR IMMEDIATE RELEASE - September 6, 2013 - General Mills announced today a voluntary Class II recall of a limited quantity of refrigerated Pillsbury Cinnamon Rolls with Icing.

No other flavors or varieties of Pillsbury Cinnamon Rolls or Pillsbury dough products are being recalled. Pillsbury Flaky Cinnamon Rolls and Pillsbury Grands! Cinnamon Rolls are not included in this recall.

This action is being taken as a precaution because the dough may contain fragments from a broken piece of plastic on the production line. These products are sold in grocery stores nationally. No other Pillsbury dough products are being recalled.

Only specific 8-count single and double packages with certain date codes of Pillsbury Cinnamon Rolls with Icing are being recalled:
Product   Better if Used Date on Package
Pillsbury Cinnamon Rolls with Icing   30OCT2013 and 31OCT2013
Pillsbury Cinnamon Rolls with Icing 2-pack   18OCT2013, 26OCT2013 and 31OCT2013

Consumers who have products covered by this recall are urged to contact General Mills for a replacement. Consumers with questions may contact General Mills toll-free at 1-800-775-4777.

 

Larry Lyons:

--- Quote from: Mimi on September 09, 2013, 03:25:26 AM ---Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 
McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of
Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz.

Contact
Consumer:
1-877-414-7709
 

FOR IMMEDIATE RELEASE - September 6, 2013 - McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). McNeil is asking retailers to remove the affected 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.

FULL RECALLED PRODUCT LIST:
Product    Lot #    UPC Code    Case UPC Code
Concentrated MOTRIN® Infants’ Drops
Original Berry Flavor 1/2 fl oz bottles

NDC 50580-100-18    DCB3T01    300450524157    30300450524158
DDB4R01
DDB4S01

After releasing these three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing. This lot was not released to the market. 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 Original Berry Flavor 1/2 fl oz. Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. 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.

Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

    Online: www.fda.gov/medwatch/report.htm
    Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
    Fax: 1-800-FDA-0178.

--- End quote ---
Motrin is not without significant risks. There have been numerous cases of stomach bleeds among adults, including deaths from taking Motrin and the other brands of nonsteroidal anti inflamatory drugs. (NSAIDs)

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