Bella Pharmaceuticals Recalls Calcium Chloride Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling specific lots of Calcium chloride 10% 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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable medication is classified as Severe (Score 4), particularly given the potential for serious injury from non-sterile administration.
Plain-English summary
Bella Pharmaceuticals, Inc. is recalling Calcium chloride 10%, 10 mL vials (Lot # 071217CC, Exp. 10/12/18). The recall was initiated because the company lacks assurance of the sterility of the product.
The affected product is prescription-only and was distributed nationwide within the USA. The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the use of these vials.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or Bella Pharmaceuticals for further instructions on how to return the product.
The recalled product
- Product
- Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Manufacturer
- Bella Pharmaceuticals, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- 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 #: 071217CC
- Exp. 10/12/18
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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