Gatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance
Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are reported in the text, the lack of sterility assurance for an ophthalmic product poses a significant risk of serious infection, aligning with the Severe classification for Class II recalls with potential for significant harm.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling 38 doses of Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, specifically including Lot #s 10092013@5 and 10162013@2.
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 Gatifloxacin drops 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 products and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
- 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@5
- 10162013@2
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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