Bella Pharmaceuticals Recalls Mannitol 20% Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling Mannitol 20% 10 mL vials because the company cannot ensure the product is sterile.
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 with potential for adverse health consequences (such as sterility issues in injectable drugs) map to a score of 4 (Severe), as they are not Class I (Critical) but represent a significant risk requiring strict handling.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling Mannitol 20%, 10 mL vials (Lot # 070717ML, Exp. 1/7/18) due to a lack of assurance of sterility. The product is prescription-only and was distributed nationwide within the USA.
The recall is being conducted because the manufacturer cannot guarantee that the vials are sterile. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact Bella Pharmaceuticals at 1 (877) BELLA for further instructions or to return the product.
The recalled product
- Product
- Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 10
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 #: 070717ML
- Exp. 1/7/18
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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