Bella Pharmaceuticals Recalls Fluorescein Sodium Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling 644 vials of Fluorescein Sodium due to a lack of assurance of sterility. The affected lot was distributed nationwide.
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, FDA Class II recalls are typically scored as 4 (Severe), especially when involving potential contamination or sterility issues in medical products, even if specific hospitalization reports are not explicitly detailed in the provided snippet.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 644 vials of Fluorescein Sodium, 5mL vials, Rx only. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot # BPFS41717 with an expiration date of 4/1/18.
The product was distributed nationwide within the USA. Fluorescein Sodium is a prescription-only medication typically used for ophthalmic procedures. The specific risk associated with the lack of sterility assurance is not detailed in the source text, but it implies a potential contamination issue.
Consumers and healthcare providers should stop using the affected product and contact Bella Pharmaceuticals at 1 (877) BELLA for further instructions or a refund. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 644
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 (2)
- Lot #: BPFS41717
- Exp. 4/1/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Bella Pharmaceuticals, 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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