The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1152-2017·Announced 2017-09-20

Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns

Bella Pharmaceuticals is recalling 7 vials of Methylcobalamin 10mg due to a lack of assurance of sterility. The product was distributed nationwide in the United States.

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 sterility issues in injectable products) are categorized as Severe (Score 4), particularly when structural or significant injury risks are implied by the lack of sterility assurance.

Plain-English summary

Bella Pharmaceuticals, Inc. is recalling 7 vials of Methylcobalamin 10mg (10mg/ml), 30 mL vials, prescription only. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot # BPMC30072917 with an expiration date of 1/29/18.

The product was distributed nationwide within the United States. The FDA has classified this recall as Class II, which indicates that 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 their healthcare provider or the recalling firm for further instructions. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Methylcobalamin 10mg, (10mg/ml), 30 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
7

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 #: BPMC30072917
  • Exp. 1/29/18

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 →

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