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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 #[email protected] (Exp. 11/3/13)
- Bevacizumab Lot #[email protected] (Exp. 11/3/13)
- Lidocaine/phenylephrine Lot #[email protected] (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.
