Washington, DC—Three pharmaceutical companies have recalled several of their products voluntarily due to sterility concerns and mold.
Avella Specialty Pharmacy has recalled two of its compounded sterile medications—bevacizumab 1.25 mg/0.05 mL PF (Lot no.: 12-20130508@179) and vancomycin PF (BSS) 1% (Lot no.: 12-20130508@181)—because of concerns of sterility assurance with its independent testing laboratory, Front Range Laboratories.
The FDA notified Avella of the issues after a recent inspection of Front Range Labs.
The agency had observed methods used to assess sterility and other qualities, like strength and stability, which could have resulted in the specialty pharmacy receiving inaccurate laboratory test results on the specified lots.
Because of the issues found, the FDA said the test result obtained by Front Range Labs might not be reliable.
Avella has discontinued its relationship with Front Range Labs as a result of this issue.
To date, the specialty pharmacy has not received any reports of adverse events related to the recall.
The products recalled were dispensed directly to healthcare providers nationwide.
Avella is notifying customers of the voluntary recall by phone and mail. Customers that have any of the medications that are being recalled should immediately discontinue use and return the unused portion to Avella.
Leiter’s Compounding Pharmacy has also voluntarily recalled three of its sterile products due to the sterility concerns at Front Range Labs.
The products and lot numbers being recalled are:
· Bevacizumab, Lot no. 08052013@1
· Bevacizumab, Lot no. 08052013@4
· Lidocaine/phenylephrine, Lot no. 07302013@6
Like Avella, the compounding pharmacy has not received any reports of adverse events or reports of contamination. The issues found also caused the FDA to conclude that the results obtained from the laboratory might not be reliable.
The recalled products were dispensed to health-care providers between Aug. 5 and Sept. 2 nationwide.
Facilities that have a product that is being recalled should stop using and return them to the compounding pharmacy.
“We are working hard to minimize any impact on our valued customers as we continue to provide high-quality compounded medications to patients,” said Charles Leiter, PharmD, president of Leiter’s Compounding Pharmacy.
Lastly, Altaire Pharmaceuticals Inc. is voluntarily recalling nine lots of its carboxymethylcellulose sodium 0.5% ophthalmic solution, 30-ml, due to reports of mold.
There have been no reports of adverse effects to consumers thus far.
The pharmaceutical company chose to recall the product after there were complaints of mold found in the 30 mL bottles after use. This caused concerns regarding the product’s effectiveness after use and handling of the product by customers.
It has been confirmed by Altaire that all lots of the product were sterile at the time of release, and the preservative was effective when challenged against the USP Preservative Effectiveness Test.
The product recalled is generically known as carboxymethylcellulose sodium 0.5% ophthalmic solution and is labeled as:
· Equate Restore Tears lubricant eye drops, 1 fl oz (30 ml); distributed by Wal-Mart Stores Inc.
· Lubricant eye drops for mild to moderate dry eye, sterile, 1 fl oz (30 ml); distributed by CVS Pharmacy Inc. and Target Corp.
Only the lots listed below are affected and the recall is limited to the product in the 30-ml size:
· 11440, labeled for CVS
· 11441, labeled for CVS
· 12042, labeled for Wal-Mart and CVS
· 12103, labeled for Wal-Mart
· 12203, labeled for Wal-Mart and CVS
· 12207, labeled for Wal-Mart
· 12293, labeled for Wal-Mart
· 12352, labeled for Target and CVS
· 12356, labeled for Target and CVS
Altaire is initiating the recall as a precautionary measure and is notifying customers by phone or letters.