Bella Pharmaceuticals Recalls B-Complex Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.
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, an FDA Class II recall involving a significant hazard such as lack of sterility (which implies a risk of infection) falls under the 'Severe' category, particularly when structural or significant injury risks are implied by the defect type.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling 45 vials of B-Complex, 30 mL vials, prescription only. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by Lot # BPBC3080517 with an expiration date of 2/5/18. The product was distributed nationwide within the USA.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the recalled lot.
The recalled product
- Product
- B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 45
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 #: BPBC3080517
- Exp. 2/5/18
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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