Leiter’s Compounding Pharmacy has voluntarily issued a nationwide recall of three lots of sterile products due to concerns regarding its independent testing lab, Front Range Laboratories, according to a release from the U.S. Food and Drug Administration.
See Also
FDA issues warning about counterfeit bevacizumab ...
FDA recalls Cytosol balanced salt solution
FDA: Do not use sterile products from NuVision Pharmacy ...
The lots being recalled are bevacizumab Lot No. 08052013@1, expiry 11/03/13; bevacizumab Lot No. 08052013@4, expiry 11/03/13; and lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13.
The Avastin (bevacizumab, Genentech) and lidocaine/phenylephrine products, dispensed to providers between Aug. 5 and Sept. 2, have not led to any reports of adverse events or contamination at this time, the release said.
Leiter’s is notifying prescribing physicians and arranging for return of products from these lots. Facilities in possession of products from these lots should stop using them.
To return products from these lots, or for additional information about the recall, providers should call Leiter’s at 1-800-292-6772 between 8 a.m. and 5 p.m. PST, Monday through Friday.
For more on compounding pharmacies, see the cover story from the current print edition of the Ocular Surgery News U.S. Edition: Drug contamination cases spur scrutiny of compounding pharmacies and vote in our compounding pharmacy safety poll.
http://www.healio.com/ophthalmology/regulatory-legislative/news/online/%7B133de592-2478-430c-bc50-8e676a0238c1%7D/leiters-compounding-pharmacy-recalls-bevacizumab-lots
No comments:
Post a Comment