Specialty Medicine Compounding Pharmacy Recalls Fluconazole and Gentamicin Solution
Specialty Medicine Compounding Pharmacy is recalling fluconazole and gentamicin solution 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for serious injury (such as sterility failure in a sterile compounded drug) are classified as Severe.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L solution. The recall includes products manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # 10042013@7. The affected product is a prescription-only sterile compounded solution.
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. As a result, the sterility of the recalled fluconazole and gentamicin solution cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Compounded Sterile Drug
- 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 (3)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #: 10042013@7
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
See all →- Severe
- SevereSpecialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
- SevereHyaluronidase Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2014-01-22
- SeverePhenol Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SevereCyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereGentamicin Buffered Recall Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereVancomycin Recall Due to Sterility Concerns at Compounding Pharmacy
FDA (Drugs) · 2013-07-10
- SevereGentamycin Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- SevereClinical Specialties Compounding Pharmacy Recalls Mitomycin Solution Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SeverePharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20