Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns
Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as lack of sterility assurance in injectable products are categorized as Severe.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 578 vials of Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV. The product is identified by NDC 69623-211-31 and barcode 2 69623 21131 0. The recall covers all lots remaining within their expiry dates.
The FDA classified this as a Class II recall because an inspection found insufficient environmental controls, potential cross-contamination, and a lack of product-specific process validations. These issues can result in a lack of sterility assurance for the ophthalmic injection.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Ophthalmic Injection
- Affected units
- 578
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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