FDA Finds Quality Control Problems At Another Johnson & Johnson Plant

Federal drug inspectors have found problems with yet another Johnson and Johnson drug manufacturing plant, this time located in Lancaster, Pennsylvania. 

The drug maker confirmed reports this week that it received a report from the FDA that indicates there are deficiencies at the plant, which is a joint venture between Johnson & Johnson and Merck Consumer Pharmaceuticals. Pepcid is one of the products manufactured at the plant.

The FDA report, known as a Form 483, is not yet available to the public because it contains sensitive industry information that needs to be redacted before it can be released. Neither Johnson and Johnson nor Merck have released any details about the deficiencies found at the plant.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The inspection report comes after Johnson & Johnson has issued a number of recalls as a result of problems with quality control at other plants, particularly through its McNeil Healthcare subsidiary.

On April 30, a recall was announced for nearly 40 liquid children’s medications made by McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency. As a result of the problems, the FDA issued a warning letter about quality control issues at the Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.

The recall affected 136 million bottles of children’s medications, resulting in the shutdown of the plant and the suspension of production of all of McNeil’s children medications. Following that recall, the FDA has received nearly 800 complaints, including at least seven reports of deaths associated with the medication. However, the FDA says its investigations so far have not directly linked any of the recalled products to any of the deaths.

In addition, the company has issued a series of Johnson and Johnson drug recalls for a variety of drugs due to chemical contamination from wood pallets that give the drug a musty smell and have caused a number of people to fall ill. The problem is due to contamination by trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, which seeped into bottles from wood pallets treated with pesticide. The contaminated drugs had a moldy smell and made some users sick.


  • Concerned ParentJuly 23, 2010 at 2:27 pm

    There is no excuse for these types of issues, especially when it pertains to the health and safety of children. The Executive Management of these facilities should face criminal charges and be sent to jail.

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Management of Ozempic Lawsuit Pretrial Proceedings To Be Reassigned Following Death of MDL Judge
Management of Ozempic Lawsuit Pretrial Proceedings To Be Reassigned Following Death of MDL Judge (Posted today)

The judge overseeing Ozempic lawsuits consolidated in federal court has died, requiring a new judge to be assigned to oversee coordinated pretrial proceedings over claims the diabetes drug and similar medications caused stomach paralysis and other intestinal complications.

Baby Food Injury Lawyers Appointed To Leadership Roles in Autism, ADHD Lawsuits Over Heavy Metal Contamination
Baby Food Injury Lawyers Appointed To Leadership Roles in Autism, ADHD Lawsuits Over Heavy Metal Contamination (Posted 2 days ago)

A group of 19 plaintiffs' lawyers have been appointed to serve in various leadership position during the consolidated pretrial proceedings for all baby food injury lawsuits, taking actions that benefit all families pursuing claims for children diagnosed with autism, ADHD or other developmental problems from toxic heavy metals found in many popular products sold in recent years.