The Recall Desk
SevereFDA (Drugs)·D-443-2014·Announced 2014-01-22

Specialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.

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 the hazard involves a lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or death from infection.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of QUAD MIX and SUPER QUAD MIX injectables. These products contain pavaperine HCl, phentolamine, prostaglandin, and atropine sulfate. The recall covers products manufactured and distributed between July 1, 2013, and October 19, 2013.

The recall is being conducted because the sterile compounded human and veterinary products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled products cannot be assured.

The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Specific lot numbers involved include t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, and t09252013@12. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, pr
Manufacturer
Specialty Medicine Compounding Pharmacy
Category
Drug — Compounded Injectable
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 (11)

  • All unexpired lots
  • manufactured and distributed between 07/01/2013 and 10/19/2013
  • including Lot #s:t09192013@20
  • t07312013@12
  • t07312013@13
  • t09172013@30
  • t08142013@10
  • t08272013@28
  • t09052013@32
  • 09162013@40
  • t09252013@12

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Specialty Medicine Compounding Pharmacy 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 51 products in this recall →

Related recalls

Same manufacturer · Specialty Medicine Compounding Pharmacy

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Same hazard · sterility

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