The Recall Desk
SevereFDA (Drugs)·D-1186-2106·Announced 2016-07-20

Medaus Recalls GABA 50mg/mL Vials Due to Sterility Concerns

Medaus, Inc. is recalling GABA 50mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

What this means for you

Illness, injury, or structural failure has been reported. 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 in a pharmaceutical product presents a significant risk profile consistent with a Severe rating under the provided criteria for Class II recalls with potential for serious harm.

Plain-English summary

Medaus, Inc. is recalling GABA 50mg/mL (PF) 50mL vials due to a lack of assurance of sterility. The affected product is identified by Lot # 160315-14 with a beyond-use date of 09/11/16. The total quantity involved is 110 mL in vials.

The recall is classified as FDA Class II by the U.S. Food and Drug Administration. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a return.

The recalled product

Product
GABA 50MG/ML (PF), 50ML 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 (2)

  • Lot #: 160315-14
  • BUD: 09/11/16

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 →

Related recalls

Same manufacturer · Medaus, Inc.

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Same hazard · sterility

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