Recall: Sterility Concerns With Leiter's Pharmacy Injectables

Leiter's Compounding Pharmacy announced a voluntary recall of three lots of sterile injectable products due to concerns with sterility assurance with its independent testing laboratory, Front Range Laboratories.  

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The FDA investigators observed that methods used by Front Range Laboratories to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. 

The affected products are as follows:

  • Bevacizumab Lot #08052013@1 (Exp. 11/3/13)
  • Bevacizumab Lot #08052013@4 (Exp. 11/3/13)
  • Lidocaine/phenylephrine Lot #07302013@6 (Exp. 10/28/13)

Patients could be at risk of contracting potentially fatal infections if exposed to non-sterile injectable products.

Bevacizumab is an angiogenesis inhibitor indicated in the treatment of various renal, CNS, colorectal, and respiratory cancers. Lidocaine/phenylephrine is a combination of a local anesthetic and a sympathomimetic drug.

Leiter's Compounding Pharmacy is notifying prescribers by mail, telephone, and/or email and is arranging for return of all recalled products.

For more information call (800) 292-6772  or visit the FDA Safety Alert page.