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.
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.