Premier Pharmacy Labs Recalls Mitomycin Vials Due to Labeling Error
Premier Pharmacy Labs is recalling 193 vials of Mitomycin 40 mg/mL due to a label error on the declared strength.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a labeling error on declared strength, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 193 vials of Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV. The recall is being conducted because of a labeling error regarding the declared strength of the medication.
The affected product is identified by Lot: MIT100217SVDS and has a beyond-use date of 03/01/2018. The product was distributed nationwide. The NDC for the product is 69623-160-35.
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 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 193
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 (1)
- Lot: MIT100217SVDS BUD: 03/01/2018
Distribution
Distributed nationwide across the United States.
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