Specialty Medicine Compounding Pharmacy Recalls EDETATE DISODIUM Ophthalmic Solution
Specialty Medicine Compounding Pharmacy is recalling EDETATE DISODIUM ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of infection associated with non-sterile ophthalmic products.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of EDETATE DISODIUM (0.05M) 1.7% Ophthalmic Solution. The affected product is a prescription-only ophthalmic solution in 30 mL containers. The recall includes lots manufactured and distributed between July 1, 2013, and October 19, 2013, specifically Lot #s t07312013@36 and t09182013@5.
The recall is being conducted because the sterile compounded products were prepared in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the EDETATE DISODIUM solution cannot be assured. The agency has classified this recall as Class II.
The product was 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 recalling firm for further instructions.
The recalled product
- Product
- EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, 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 (4)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: t07312013@36
- t09182013@5
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.
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