Agency classClass IIOur severity:Severe FDA (Drugs)·D-453-2014·Announced 2014-01-22

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

Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risk factors such as sterility assurance failures in injectable products are categorized as Severe.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of TRIPLE MIX 15 mg/1 mg/20 mcg/mL INJECTABLE and TRIPLE MIX 30 mg/1 mg/20 mcg/mL INJECTABLE. These prescription-only sterile compounded products contain papaverine hydrochloride, phentolamine, and prostaglandin. The recall covers 44 mL vials manufactured and distributed between July 1, 2013, and October 19, 2013, including specific lot numbers t09032013@48, t09252013@37, and 09162013@38.

The recall is being conducted because the 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 Triple Mix products cannot be assured. The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only.

Patients and healthcare providers should stop using the recalled products and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product: TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer: Specialty Medicine Compounding Pharmacy
Category: Drug — Injectable Compounded Medication
Hazard: sterility-failure
infection-risk

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 (5)

All unexpired lots
manufactured and distributed between 07/01/2013 and 10/19/2013
including Lot #s: t09032013@48
t09252013@37
09162013@38

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 →

Same manufacturer · Specialty Medicine Compounding Pharmacy

See all →

Severe
Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
Severe
Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
Severe
Hyaluronidase Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2014-01-22
Severe
Phenol Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
Severe
Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22

Same hazard · sterility failure