Mitomycin 0.04% Solution Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin 0.04% 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. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin 0.04% solution. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the product.
The affected product is Mitomycin 0.04% solution, 50ml total. The specific lots involved are Lot number CABDAGAD:25 and Lot number CABDAGAD:84, both with an expiration date of 4/20/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 50
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 CABDAGAD:25
- Exp date: 4/20/2013 and Lot number CABDAGAD:84
- Exp date: 4/20/2013.
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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