Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise 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, which corresponds to a Severe rating under the rubric due to the potential for serious health consequences from a lack of sterility assurance in a medical product.
Plain-English summary
Premier Pharmacy Labs Inc is voluntarily recalling 1,834 vials of Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, NDC 69623-160-35. The product is a prescription-only medication distributed nationwide in the United States.
The recall was initiated following an FDA inspection that identified insufficient environmental controls, potential cross-contamination, and a lack of product-specific process validations. These deficiencies may result in a lack of sterility assurance for the affected vials.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The recall covers all lots remaining within their expiration dates.
The recalled product
- Product
- Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Ophthalmic / Irrigation
- Affected units
- 1,834
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Premier Pharmacy Labs Inc 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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