Bella Pharmaceuticals Recalls Magnesium Chloride Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling Magnesium Chloride 200mg 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling Magnesium Chloride 200mg, 30mL vials (Lot #: BPMC08517, Exp. 2/5/18). The recall was initiated due to a lack of assurance of sterility.
The affected product is prescription-only and was distributed nationwide within the USA. The recall involves 5 vials per unit.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or Bella Pharmaceuticals for further instructions.
The recalled product
- Product
- Magnesium Chloride 200mg, 30m L 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
- 5
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 #: BPMC08517
- 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.
See all 16 products in this recall →Related recalls
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