EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/194331
October 2013
Food and Drug Administration
(FDA) alerts providers of three
recalls of ophthalmic-related drugs
T
he FDA issued three separate alerts to providers informing them of
voluntary national recalls of specific lots of drugs used in ophthalmology. The recalls affect, among other products, Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and Bevacizumab.
Altaire Pharmaceuticals: Carboxymethylcellulose Sodium 0.5%
Ophthalmic Solution, 30 mL
Altaire issued a voluntary recall of a total of nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL. There have been no
reports of adverse effects to consumers so far. However, due to complaints
of mold found in the 30 mL bottles after use, concerns regarding the
effectiveness of the preservative after use and handling of the product by
consumers have prompted the recall.
The product is known generically as Carboxymethylcellulose Sodium
0.5% Ophthalmic Solution and labeled as follows:
• Equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose
Sodium 0.5%, Sterile, 1 fl oz (30 mL) – Distributed by Wal-Mart Stores;
• Lubricant eye drops for mild to moderate dry eye, sterile, 1 fl oz (30 ml)
– Distributed by CVS Pharmacy;
• Lubricant eye drops for mild to moderate dry eye, sterile, 1 fl oz (30 ml)
– Distributed by Target Corp.
Only the lots listed below are affected, and the recall is limited to the
product in the 30 mL size:
• Lot # 11440, expiration date 09/2013, labeled for CVS;
• Lot # 11441, expiration date 09/2013, labeled for CVS;
• Lot # 12042, expiration date 01/2014, labeled for Wal-Mart and CVS;
• Lot # 12103, expiration date 02/2015, labeled for Wal-Mart;
• Lot # 12203, expiration date 05/2015, labeled for Wal-Mart and CVS;
• Lot # 12207, expiration date 05/2015, labeled for Wal-Mart;
• Lot # 12293, expiration date 08/2015, labeled for Wal-Mart;
• Lot # 12352, expiration date 09/2015, labeled for Target and CVS;
• Lot # 12356, expiration date 09/2015, labeled for Target and CVS.
Rhein Fire & Ice Mask
Aids In Reducing Dry Eye Symptoms
Avella Specialty Pharmacy: Bevacizumab 1.25 mg/0.05 mL PF
and Vancomycin PF (BSS) 1%
For Heat Therapy!
For Cold Therapy!
Can Be Used Multiple Times!
Avella Specialty Pharmacy voluntarily recalled two compounded sterile
medications: Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS)
1%. The recall is a result of concerns of sterility assurance with the
specialty pharmacy's independent testing laboratory, Front Range
Laboratories.
Avella recalled the following lots:
• Bevacizumab 1.25 mg/0.05 mL PF; Lot #: 12-20130508@179;
expiration date: 11/3/2013
• Vancomycin PF (BSS) 1%; Lot #: 12-20130508@181;
expiration date: 10/4/2013
Avella was notified that in a recent inspection of Front Range Labs,
FDA investigators observed methods used to assess sterility and other
qualities (e.g., strength and stability) that may have resulted in Avella
receiving inaccurate laboratory test results on the specified lots. The FDA
has raised concerns that test results obtained from Front Range Labs may
not be reliable.
VIDEO
Leiter's Compounding Pharmacy:
Specific Lots of Bevacizumab and Lidocaine
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