Tropicamide 1% Ophthalmic Solution Recalled Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Tropicamide 1% Ophthalmic Solution 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 involves a lack of assurance of sterility in a compounded pharmaceutical product, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Tropicamide 1% Ophthalmic Solution, 5.5 mL, manufactured and distributed between July 1, 2013, and October 19, 2013. The recall includes Lot # t10142013@30 and other unexpired lots from this period.
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 Tropicamide 1% Ophthalmic Solution cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
- 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 #: t10142013@30
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 concern
See all →- HighSegmental Stem Components for ELEOS Limb Salvage System Recalled
FDA (Devices) · 2025-06-04
- HighMEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
FDA (Devices) · 2024-10-16
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- HighExactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
FDA (Devices) · 2024-06-26
- HighPantoprazole Sodium for Injection Recalled Due to Sterility Concern
FDA (Drugs) · 2023-09-20