The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1211-216·Announced 2016-07-20

Medaus Recalls Magnesium Chloride Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Magnesium Chloride 200mg/mL vials because the company cannot assure the sterility of the product.

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. Per the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable product) without explicit reports of hospitalization or death is scored as 4 (Severe), as it exceeds the threshold for 'High' (3) due to the potential for serious adverse health consequences associated with non-sterile injectables.

Plain-English summary

Medaus, Inc. is voluntarily recalling specific lots of Magnesium Chloride 200mg/mL (PF) in 5mL and 10mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product. The affected lots are 160203-19 (Best Use Date: 08/01/16) and 160222-60 (Best Use Date: 08/20/16).

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 5,000 mL in vials.

Consumers and healthcare providers should stop using the affected lots and contact Medaus, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable
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 (5)

  • a) Lot #: 160203-19
  • BUD: 08/01/16
  • Lot #: 160222-60
  • BUD: 08/20/16. b) Lot #: 160203-19
  • BUD: 08/20/16.

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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