Agency classClass IIOur severity:Severe FDA (Drugs)·D-1229-2016·Announced 2016-07-20

Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in injectable products which carry significant risk.

Plain-English summary

Medaus, Inc. is recalling specific lots of NA ASCORBATE 500MG/ML NON-CORN (PF) in 10mL, 50mL, and 100mL vials. The recall was initiated due to a lack of assurance of sterility. The affected product was distributed in the United States, Japan, and New Zealand.

The recall covers 358,000 mL of vials across multiple lot numbers with expiration dates ranging from May 29, 2016, to August 9, 2016. Specific lot numbers include 151201-30, 151209-26, 151216-63, 151231-11, 160105-4, 160125-41, 160211-20, and 160511-20.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not used. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Manufacturer: Medaus, Inc.
Category: Drug — Injectable Solution
Hazard: sterility
infection

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 (17)

a) Lot #: 151201-30
BUD: 05/29/16
Lot #: 151209-26
BUD: 06/06/16
Lot #: 151216-63
BUD: 06/13/16
Lot #: 151231-11
BUD: 06/28/16
Lot #: 160105-4
BUD: 07/03/16
Lot #: 160125-41
BUD: 07/23/16
Lot #: 160211-20
BUD: 08/09/16. b) Lot #: 151201-30
Lot #: 160511-20
BUD: 08/09/16. c) Lot #: 151201-30
BUD: 08/09/16.

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 →

Same manufacturer · Medaus, Inc.

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