Tetracaine Solution Recalled for Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Tetracaine 0.25% solution 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a medical product, which meets the rubric criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Tetracaine (buffered) 0.25% solution. The recall involves 474ml total of the product, distributed in Florida, Georgia, and South Carolina. Specific lot numbers affected are CABDCCAB:46 (expiring 4/22/2013), CABDAGAC:58 (expiring 5/7/2013), and CABDAGAD:07 (expiring 6/4/2013).
The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes and the assurance of sterility for the product. The agency has classified this as a Class II recall.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Affected units
- 474
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 CABDCCAB:46
- Exp date: 4/22/2013
- Lot number CABDAGAC:58
- Exp date: 5/7/2013 and Lot number CABDAGAD:07 Exp date: 6/4/2013.
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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