The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1220-2016·Announced 2016-07-20

Medaus Recalls M.I.C. 25/50/50 Vials Due to Sterility Concerns

Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) vials because the company cannot ensure the product is sterile. The recall covers multiple lots distributed in the U.S., Japan, and New Zealand.

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 involving significant risks such as sterility assurance failures are categorized as Severe (Score 4).

Plain-English summary

Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is available in 187 mL vials.

The recall includes nine specific lots with expiration dates ranging from May 2016 to July 2016. The affected lots were distributed nationwide in the United States, as well as in Japan and New Zealand.

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
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Pharmaceutical
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 (12)

  • Lot #: 151130-48
  • BUD: 05/26/16
  • Lot #: 151215-7
  • Lot #: 151216-12
  • Lot #: 160106-27
  • Lot #: 160113-38
  • BUD: 07/11/16
  • Lot #: 160223-33
  • BUD: 07/31/16
  • Lot #: 160307-36
  • Lot #: 160307-52
  • Lot #: 160308-5

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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