The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1215-2016·Announced 2016-07-20

Medaus Recalls Methyl B12 and Pyridoxine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Methyl B12 and Pyridoxine vials because the company cannot guarantee 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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant risk (lack of sterility) is categorized as Severe (Score 4), as it is not a Class I (Critical) but involves a potential for adverse health consequences.

Plain-English summary

Medaus, Inc. has initiated a recall of Methyl B12 1000mcg/mL/Pyridoxine 100mg vials containing benzalkonium 0.01% preservative. The recall affects 1 mL and 10 mL vials, specifically Lot # 160222-85 with a best-use date of 07/05/16. The product was distributed in the United States, Japan, and New Zealand.

The recall is being conducted due to a lack of assurance of sterility. The FDA has classified this as a Class II recall, 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 Medaus, Inc. for further instructions or a refund. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Medication
Hazard

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 (3)

  • a) Lot #: 160222-85
  • BUD: 07/05/16. b) Lot #: 160222-85
  • BUD: 07/05/16.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 88 recalled by Medaus, 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 88 products in this recall →

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