Agency classClass IIOur severity:Severe FDA (Drugs)·D-414-2014·Announced 2014-01-22

Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns

Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection from non-sterile medical products.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Combo Eye Gel, a prescription sterile compounded product containing cyclopentolate, tropicamide, diclofenac sodium, ciprofloxacin, phenylephrine, and lidocaine jelly. The recall includes products manufactured and distributed between July 1, 2013, and October 19, 2013, specifically Lot #s 10092013@4 and 10162013@1.

The recall was initiated 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 Combo Eye Gel 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 product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product: Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer: Specialty Medicine Compounding Pharmacy
Category: Drug — Compounded Sterile Product
Hazard: lack-of-sterility
infection-risk
Affected units: 38

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)

All unexpired lots
manufactured and distributed between 07/01/2013 and 10/19/2013
including Lot #s: 10092013@4
10162013@1

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
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
Severe
Sodium Thiosulfate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22

Same hazard · lack of sterility