The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1200-2016·Announced 2016-07-20

Medaus Recalls Lidocaine 2% Vials Due to Sterility Concerns

Medaus, Inc. is recalling Lidocaine 2% (PF) in NaCl 10mL vials due to a lack of assurance of sterility. The product was 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, an FDA Class II recall involving a drug with a sterility defect (which implies a risk of infection) falls under the 'Severe' category, as it is not a Class I recall but involves a significant potential health risk.

Plain-English summary

Medaus, Inc. is recalling Lidocaine 2% (PF) in NaCl, 10mL vials, manufactured by Medaus Pharmacy. The recall was initiated because of a lack of assurance of sterility. The affected product includes specific lots with expiration dates ranging from May 31, 2016, to August 29, 2016.

The recalled vials were distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 147 mL in vials.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a return. This recall is classified as Class II by the FDA, 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
LIDOCAINE 2% (PF) IN NACL, 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 (15)

  • Lot #: 151203-48
  • BUD: 05/31/16
  • Lot #: 151204-9
  • BUD: 06/01/16
  • Lot #: 151218-20
  • BUD: 06/15/16
  • Lot #: 160125-23
  • BUD: 07/23/16
  • Lot #: 160125-24
  • Lot #: 160125-25
  • Lot #: 160127-6
  • BUD: 07/25/16
  • Lot #: 160302-76
  • BUD: 08/29/16
  • Lot #: 160302-77

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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