The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1232-2016·Announced 2016-07-20

Medaus Recalls Procaine 2% Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Procaine 2% 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug represents a significant risk that aligns with the Severe criteria for Class II drug recalls.

Plain-English summary

Medaus, Inc. is recalling specific lots of Procaine 2% (PF) in 2 mL and 10 mL vials. The recall was initiated because the company lacks assurance of the sterility of the product. The affected lots include 160112-47 with a best-use date of 07/10/16 and 160225-9 with a best-use date of 08/23/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 1,500 mL in vials.

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

The recalled product

Product
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Anesthetic
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 #: 160112-47
  • BUD: 07/10/16
  • Lot #: 160225-9
  • BUD: 08/23/16. b) Lot #: 160112-47
  • BUD: 08/23/16.

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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