Clinical Specialties Compounding Pharmacy Recalls Cataract Drops Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling cataract drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which poses a risk of harm even without reported injuries.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of cataract drops. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes and the assurance of sterility for the product.
The affected product is 80 ml of cataract drops. The specific lots involved are CABDAEAC:07 with an expiration date of 5/5/2013, and CABCCIBC:44 with an expiration date of 3/28/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers who have these specific lots of cataract drops should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return the product.
The recalled product
- Product
- Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot number CABDAEAC:07
- Exp date: 5/5/2013
- Lot number CABCCIBC:44
- Exp date: 3/28/2013
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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