PlainRecalls
FDA Drug Moderate Class II Terminated

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, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reported: January 22, 2014 Initiated: October 19, 2013 #D-443-2014

Product Description

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, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reason for Recall

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Details

Units Affected
86 mL
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
Location
South Lyon, MI

Frequently Asked Questions

What product was recalled? ▼
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, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178. Recalled by Specialty Medicine Compounding Pharmacy. Units affected: 86 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-443-2014.

Related Recalls

CPSC Moderate

Vive Health Recalls Adult Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; V…

Ningbo Shenyu Medical Equipment Co., Ltd., of China · 2026-02-19
CPSC Moderate

Beloems Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Viol…

Leioujiapin Technology Co., Ltd. dba Beloems, of China · 2026-02-12
CPSC Moderate

Fortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxia…

Guangzhou Kezhinuo Maoyi Youxian Gongsi, dba Fortemotus Direct US, of China · 2026-02-12
CPSC Moderate

Airova Recalls Aroeve Air Purifiers Due to Fire and Burn Hazards

· 2026-02-09
CPSC Moderate

Aterian Recalls PurSteam Elite Travel Steamers and Mighty Lil Steamers Due to Risk of Serious Burn Injury

· 2026-02-05

Explore Related Data

Vehicle Safety → Drug Information →