Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel
Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for serious health consequences (such as sterility issues in ophthalmic products) are rated as Severe.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel (MAR) due to concerns regarding quality control processes. The recall was initiated following FDA inspection findings that resulted in a lack of assurance of sterility for the product.
The affected product is ophthalmic dilation gel (MAR) manufactured by Clinical Specialties Compounding Pharmacy, located at 318 Baston Road, Augusta, GA 30907. The total quantity involved is 360ml. The specific lots affected are Lot number CABDBFAC:88 with an expiration date of 5/16/2013, and Lot number CABDCBAB:42 with an expiration date of 4/21/2013.
The product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the source of purchase or the recalling firm.
The recalled product
- Product
- Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
- Affected units
- 360
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 CABDBFAC:88
- Exp date: 5/16/2013
- and Lot number CABDCBAB:42
- Exp date: 4/21/2013.
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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