The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1233-2016·Announced 2016-07-20

Medaus Recalls Proline 100mg/mL Vials Due to Sterility Concerns

Medaus, Inc. is recalling Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Medaus, Inc. is recalling Proline 100mg/mL (PF), 5mL vials due to a lack of assurance of sterility. The specific product affected is identified by Lot # 160308-3 with a best-use-by date of 09/04/16. The recall is classified as FDA Class II.

The affected vials were distributed nationwide in the United States, as well as in Japan and New Zealand. The recall was initiated because the manufacturer could not guarantee that the product remained sterile, which is a critical quality attribute for injectable pharmaceuticals.

Consumers and healthcare providers should stop using the affected vials immediately. Patients who have already received the medication should contact their healthcare provider for guidance. The recall is being handled by Medaus, Inc.

The recalled product

Product
PROLINE 100MG/ML (PF), 5ML 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 (2)

  • Lot #: 160308-3
  • BUD: 09/04/16

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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