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.
What this means for you
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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