The Recall Desk
SevereFDA (Drugs)·D-981-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls MIC-CARN MAX Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling MIC-CARN MAX injectable due to FDA inspectional findings regarding quality control and sterility assurance.

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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or adverse health consequences.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., dba Rxtra Solutions, is recalling MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, for intravenous and subcutaneous use. The product was compounded in Southfield, Michigan, and distributed nationwide in the United States.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility. The specific lot codes affected are 03192013@29, 01242013@28, 05212013@23, 06252013@1, and 07022013@27.

Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, 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
MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

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 (4)

  • 03192013@29
  • 01242013@28
  • 05212013@23
  • 06252013@1 and 07022013@27

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →