Earlier this month J&J’s McNeil Consumer Healthcare unit pulled lots of its Tylenol Arthritis Pain caplet bottles in the US due to reports of nausea and stomach pain, in a move that itself was an expansion of a recall it began in December.
The latest recall covers a large number of over-the-counter drugs from the firm’s Benadryl, Motrin Aspirin and Rolaids lines and, in addition to the US, extends to products sold in the United Arab Emirates (UAE), Fiji and the Americas.
Again J&J attributed the problems to the presence of trace amounts of the TBA used to stain pallets on which components of the affected products were transported.
Investigation “unjustifiably delayed”
The recall follows a US Food and Drug Administration (FDA) warning detailing several current good manufacturing practice (cGMP) violations at a plant in Puerto Rico thought to be the source of the TBA.
In a letter issued on January 15, the FDA criticised McNeil’s response to the problem, citing numerous delays to its investigation of the issue that first emerged as long ago as 2008.
The agency also said that: “although your firm had test results indicative of contamination with TBA as the source of the off odour … since September 2009, these results were not shared with [the] FDA” until a recent inspection of the facility that concluded on January 8.