Clinical Specialties Compounding Pharmacy Recalls Mitomycin Solution Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin (modified) 0.02% solution because FDA inspection findings raised concerns about quality control processes and 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the lack of assurance of sterility in a drug product is a significant safety hazard that aligns with the Severe classification for Class II recalls involving potential serious harm.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin (modified) 0.02% solution. The recall was initiated following FDA inspection findings that resulted in concerns regarding the company's quality control processes and the assurance of sterility for the product.
The affected product is a 6ml total volume solution. The specific lots involved are Lot number CABDAGAD:68 and Lot number CABDAGAD:60, both with an expiration date of 4/20/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. Do not use the product until further notice.
The recalled product
- Product
- Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 6
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:68
- Exp date: 4/20/2013 and Lot number CABDAGAD:60
- 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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