Compounding pharmacies recall low T medications

September 13, 2013

Two California compounding pharmacies have announced voluntary recalls of testosterone products.

Two California compounding pharmacies have announced voluntary recalls of testosterone products.

Park Compounding of Irvine, CA said it is voluntarily recalling one lot of sterile medication testosterone cypionate (sesame oil), 200 mg/mL for injection in 10-mL amber vials.

The prescription preparations were sold during May and June of 2013, in California and Indiana. The products would have been sold directly to customers (pickup and by mail) and to physician offices by prescription (pickup and by mail), Park Compounding said in a press release.

Separately, University Compounding Pharmacy, San Diego is also voluntarily recalling several lots of testosterone cypionate (sesame oil), 200 mg/mL.

The prescription preparations were distributed nationwide from May 9, 2013 to Sept. 7, 2013. The preparations would have been sold directly to customers by pickup and by mail from University Compounding Pharmacy.

In both cases, FDA investigators observed that methods used by laboratories to assess sterility might have resulted in pharmacies receiving inaccurate laboratory test results. The FDA said it has concerns that results obtained from the laboratories are not reliable.

The FDA noted that to date, there have been no reported adverse events associated with the use of these products, there has been no confirmation of lack of sterility of these products, and the recalls are a precautionary measure.

Both pharmacies said they are notifying their customers by phone and mail and are arranging for return of all recalled product lots. Customers that have product that is being recalled should stop using it and contact the corresponding pharmacy to arrange for return of unused product.

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