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Regulatory Focus™ > News Articles > FDA Warns Compounding Pharmacy, Finds Wood in Drug Sample

FDA Warns Compounding Pharmacy, Finds Wood in Drug Sample

Posted 22 August 2017 | By Zachary Brennan 

FDA Warns Compounding Pharmacy, Finds Wood in Drug Sample

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to a Folcroft, PA-based compounding drug facility run by ImprimisRx after uncovering adulterated products and insanitary conditions.

During an inspection last summer, FDA inspectors took samples of two lots of a product compounded at the pharmacy and found that "fibrous material consistent with wood was present in the sample taken from one of those lots of your product."

FDA also found that the compounding pharmacy’s "cleaning and disinfecting procedures for work surfaces and utensils used for beta-lactam products are inadequate."

To address the insanitary conditions, FDA noted that the firm has stopped producing formulations with powdered penicillin and/or related beta-lactam ingredients, effective 10 November 2016.

"Your action adequately addresses our concerns and such commitment will be verified during a follow up inspection," FDA said.

ImprimisRx told Focus that its "subsidiary entity ImprimisRx PA is no longer an operational entity."

In addition to the warning letter, ImprimisRx, which in 2015 made headlines for offering a low-cost compounded version of Daraprim (pyrimethamine) after Martin Shkreli raised the price of the drug by 5,000%, has more recently been linked to infusions of curcumin that were compounded with polyethylene glycol (PEG) 40 castor oil.

On 10 March, FDA said it received an adverse event report concerning a 30-year-old female patient who experienced cardiac arrest after IV administration of a curcumin emulsion product compounded by ImprimisRx.

"The patient reportedly had a history of allergies and was being treated for eczema by a naturopathic doctor. Within minutes of starting the infusion, the patient became pulseless and required CPR. The patient suffered anoxic (depleted oxygen) brain injury and subsequently died," FDA said.

Warning Letter

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