Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of serious injury (lack of sterility in an ophthalmic product) corresponds to a severity score of 4 (Severe).
Plain-English summary
Premier Pharmacy Labs Inc is recalling 125 dropper bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only. The product is identified by NDC 69623-106-61 and barcode 1 69623 10661 9. The recall covers all lots remaining within their expiry dates.
The recall was initiated because an FDA 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 solution.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Ophthalmic Solution
- Affected units
- 125
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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