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Tuesday, May 31, 2011

Phanthom Recall 2009 - Action 2011

The FDA obtained a memo which was first sent anonymously to Oregon state regulators, which instructed a subcontractor on how to go into stores and quietly buy up batches of the bad product, without arousing any suspicions.

"You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!" reads the memo dated June 12, 2009.

The FDA could not identify the other companies involved, named in the memo as WIS and CSCS.

The FDA said it was aware that McNeil was using a contractor to remove a sample batch of the product, but not at such a wide scale.

"Once we learned of the contractor's activities, the FDA asked McNeil to initiate a recall, and the company complied," the agency said in a statement.

The original date of this trhead is March 18, 2011.

Tylenol, Motrin, Benadryl, Rolaids Recall
The FDA is taking over 3 manufacturing plants operated by Johnson & Johnson McNeil's division, because they have had so many problems with recalls due to slovenly manufacturing processes leading to contamination and mixed up ingredient.

Quote:                                                                                                                                                        McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.
McNeil's plants in Puerto Rico and Lancaster will continue to operate, McNeil spokeswoman Bonnie Jacobs said. But "there is the potential for some impact [in production] initially as we implement the additional steps."

… McNeil can continue to manufacture and ship drugs from the Las Piedras and Lancaster plants, but not from the Fort Washington facility.
The agreement also requires McNeil to destroy all drugs under its control that have been recalled from the three facilities since December 2009.

The company shut its Fort Washington plant following a scathing FDA inspection report of the factory last May that cited 20 manufacturing violations.That facility makes all of McNeil pediatric over-the-counter Tylenol, Benadryl and Motrin medicines. The other two facilities make adult medicines, including Tylenol.

The paraphrased aphorism ‘if nothing nice to say – say nothing’ is invoked with this post.

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