Clinical Specialties Compounding Pharmacy Recalls Laser Ophthalmic Drops
Clinical Specialties Compounding Pharmacy is recalling specific lots of laser ophthalmic drops due to FDA inspection findings regarding quality control and sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in ophthalmic products, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of laser ophthalmic drops, 12 mL bottles. The recall involves Lot number CABCCIBC:20 with an expiration date of 3/28/2013, and Lot number CABDAEAC:90 with an expiration date of 3/5/2013.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the lack of assurance of sterility. The affected products were distributed in Florida, Georgia, and South Carolina.
Consumers who have these specific lots of laser ophthalmic drops should stop using them and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
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 (3)
- Lot number CABCCIBC:20
- Exp date: 3/28/2013 and Lot number CABDAEAC:90
- Exp date: 3/5/2013.
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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