2010 Johnson & Johnson children's product recall
Encyclopedia
The 2010 Johnson & Johnson children's product recall was a voluntary recall
of 43 over-the-counter children's medicine
s announced by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson
, on April 30, 2010. Medications in the recall included liquid versions of Tylenol
, Tylenol Plus, Motrin, Zyrtec, and Benadryl
. The products were recalled after it was determined that they "may not fully meet the required manufacturing specifications". The recall affected at least 12 countries.
, United States. According to the Food and Drug Administration
(FDA), the plant's manufacturing process was "not in control," meaning it was using flawed procedures that could potentially lead to manufacturing errors. As a result, some products "may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny [foreign] particles." Foreign particles could potentially include solidified ingredients or "manufacturing residue such as tiny metal specks" or mold.
It was not clear when the problems began, but FDA official Douglas Stearn said it "does go back in time". The official FDA report, released May 4, said investigators found thick dust, grime, and contaminated ingredients at the manufacturing plant. Burkholderia cepacia bacteria was found on some equipment which, according to Johnson & Johnson, never was actually put into use.
, Dominican Republic
, Fiji
, Guam
, Guatemala
, Jamaica
, Kuwait
, Puerto Rico
, Panama
, Trinidad and Tobago
, the United Arab Emirates
, and the United States were affected by the recall. It includes all non-expired packages produced in the United States – more than 100,000 bottles of medicine in total. "A vast portion of the [American] children's medicine market" was affected by the recall. In Canada, only Children's Motrin
and Children's Tylenol Cough & Runny Nose were affected by the recall.
According to the FDA, consumers should stop using the recalled products even though the chance of related health problems was "remote." A McNeil spokesperson stated that the recall was not made on "the basis of adverse medical events". As of May 2, no injuries or deaths have been reported.
All production at the deficient plant has been voluntarily halted, but McNeil declined to state when the plant first ceased operations. In a statement, Johnson & Johnson said "a comprehensive quality assessment across its manufacturing operations" was underway. According to a spokesperson, fixes had already been identified by May 2, and would be put in place before operation resumed.
A dedicated website and telephone hotline were established by the company to handle customer inquiries. The phone line was initially overwhelmed by a high call volume.
Product recall
A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity...
of 43 over-the-counter children's medicine
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
s announced by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson
Johnson & Johnson
Johnson & Johnson is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500....
, on April 30, 2010. Medications in the recall included liquid versions of Tylenol
Tylenol
Tylenol is a North American brand of drugs advertised for reducing pain, reducing fever, and relieving the symptoms of allergies, cold, cough, and flu. The active ingredient of its original, flagship product, paracetamol , is marketed as an analgesic and antipyretic...
, Tylenol Plus, Motrin, Zyrtec, and Benadryl
Benadryl
Benadryl is a brand name allergy medicine marketed over-the-counter by Johnson & Johnson subsidiary McNeil Consumer Healthcare. Prior to 2007, Benadryl was marketed by Pfizer Consumer Healthcare...
. The products were recalled after it was determined that they "may not fully meet the required manufacturing specifications". The recall affected at least 12 countries.
Discovery of manufacturing problems
During a routine inspection on April 19, federal investigators found several "manufacturing deficiencies" at a McNeil manufacturing facility in Fort Washington, PennsylvaniaFort Washington, Pennsylvania
Fort Washington is an unincorporated census-designated place and suburb of Philadelphia in Montgomery County, Pennsylvania, United States. The population was 5,446 at the 2010 census.-Prior to the Revolutionary War:...
, United States. According to the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), the plant's manufacturing process was "not in control," meaning it was using flawed procedures that could potentially lead to manufacturing errors. As a result, some products "may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny [foreign] particles." Foreign particles could potentially include solidified ingredients or "manufacturing residue such as tiny metal specks" or mold.
It was not clear when the problems began, but FDA official Douglas Stearn said it "does go back in time". The official FDA report, released May 4, said investigators found thick dust, grime, and contaminated ingredients at the manufacturing plant. Burkholderia cepacia bacteria was found on some equipment which, according to Johnson & Johnson, never was actually put into use.
Recall
According to the FDA, the agency alerted Johnson & Johnson of the problem via letter on Friday, April 30. That evening, McNeil announced a voluntary recall of the affected products. According to Johnson & Johnson spokesperson Bonnie Jacob, the company had conducted an independent internal assessment and already alerted the FDA of recall plans before the letter arrived. CanadaCanada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, Dominican Republic
Dominican Republic
The Dominican Republic is a nation on the island of La Hispaniola, part of the Greater Antilles archipelago in the Caribbean region. The western third of the island is occupied by the nation of Haiti, making Hispaniola one of two Caribbean islands that are shared by two countries...
, Fiji
Fiji
Fiji , officially the Republic of Fiji , is an island nation in Melanesia in the South Pacific Ocean about northeast of New Zealand's North Island...
, Guam
Guam
Guam is an organized, unincorporated territory of the United States located in the western Pacific Ocean. It is one of five U.S. territories with an established civilian government. Guam is listed as one of 16 Non-Self-Governing Territories by the Special Committee on Decolonization of the United...
, Guatemala
Guatemala
Guatemala is a country in Central America bordered by Mexico to the north and west, the Pacific Ocean to the southwest, Belize to the northeast, the Caribbean to the east, and Honduras and El Salvador to the southeast...
, Jamaica
Jamaica
Jamaica is an island nation of the Greater Antilles, in length, up to in width and 10,990 square kilometres in area. It is situated in the Caribbean Sea, about south of Cuba, and west of Hispaniola, the island harbouring the nation-states Haiti and the Dominican Republic...
, Kuwait
Kuwait
The State of Kuwait is a sovereign Arab state situated in the north-east of the Arabian Peninsula in Western Asia. It is bordered by Saudi Arabia to the south at Khafji, and Iraq to the north at Basra. It lies on the north-western shore of the Persian Gulf. The name Kuwait is derived from the...
, Puerto Rico
Puerto Rico
Puerto Rico , officially the Commonwealth of Puerto Rico , is an unincorporated territory of the United States, located in the northeastern Caribbean, east of the Dominican Republic and west of both the United States Virgin Islands and the British Virgin Islands.Puerto Rico comprises an...
, Panama
Panama
Panama , officially the Republic of Panama , is the southernmost country of Central America. Situated on the isthmus connecting North and South America, it is bordered by Costa Rica to the northwest, Colombia to the southeast, the Caribbean Sea to the north and the Pacific Ocean to the south. The...
, Trinidad and Tobago
Trinidad and Tobago
Trinidad and Tobago officially the Republic of Trinidad and Tobago is an archipelagic state in the southern Caribbean, lying just off the coast of northeastern Venezuela and south of Grenada in the Lesser Antilles...
, the United Arab Emirates
United Arab Emirates
The United Arab Emirates, abbreviated as the UAE, or shortened to "the Emirates", is a state situated in the southeast of the Arabian Peninsula in Western Asia on the Persian Gulf, bordering Oman, and Saudi Arabia, and sharing sea borders with Iraq, Kuwait, Bahrain, Qatar, and Iran.The UAE is a...
, and the United States were affected by the recall. It includes all non-expired packages produced in the United States – more than 100,000 bottles of medicine in total. "A vast portion of the [American] children's medicine market" was affected by the recall. In Canada, only Children's Motrin
Ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....
and Children's Tylenol Cough & Runny Nose were affected by the recall.
According to the FDA, consumers should stop using the recalled products even though the chance of related health problems was "remote." A McNeil spokesperson stated that the recall was not made on "the basis of adverse medical events". As of May 2, no injuries or deaths have been reported.
All production at the deficient plant has been voluntarily halted, but McNeil declined to state when the plant first ceased operations. In a statement, Johnson & Johnson said "a comprehensive quality assessment across its manufacturing operations" was underway. According to a spokesperson, fixes had already been identified by May 2, and would be put in place before operation resumed.
A dedicated website and telephone hotline were established by the company to handle customer inquiries. The phone line was initially overwhelmed by a high call volume.
Aftermath
On May 6, The House Committee on Oversight and Government Reform launched an investigation into Johnson & Johnson, saying that the recall combined with previous recalls "point to a major problem" with the company's production. "Taken together, these recalls point to a major problem in the production of McNeil products," said a statement from the panel's leadership. The company had issued four recalls in the preceding year.List of affected products
- Children's Benadryl Allergy liquids (one variety)
- Motrin Infants' drops (three varieties)
- Children's Motrin suspensions (eleven varieties)
- Tylenol Infants' drops (seven varieties)
- Children's Tylenol suspensions (eight varieties)
- Children's Tylenol Plus suspensions (nine varieties)
- Children's Zyrtec liquids (five varieties)
External links
- McNeil Product Recall homepage
- Complete list of affected products from McNeil's website