Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable product) are categorized as Severe.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 20 vials of Sodium Bicarbonate 8.4%, 10 mL vials (Lot # BPSB8408717, Exp. 11/7/17). The recall was initiated because the company lacks assurance of the product's sterility.
The affected prescription-only medication was distributed nationwide within the United States. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lot and contact Bella Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 20
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 #: BPSB8408717
- Exp. 11/7/17
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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