The Recall Desk
SevereFDA (Drugs)·D-1147-2017·Announced 2017-09-20

Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns

Bella Pharmaceuticals is recalling Methylcobalamin 10mg 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure for an injectable drug, align with a Severe rating (Score 4) as it poses a significant risk of harm.

Plain-English summary

Bella Pharmaceuticals, Inc. is recalling Methylcobalamin 10mg (1mg/ml) 30 mL vials. 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 specific lot number is 070717MC, with an expiration date of 1/7/18.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Affected units
30

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 #: 070717MC
  • Exp. 1/7/18

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 →