Neomycin Sulfate Ophthalmic Solution Recalled Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate 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 the rubric specifies that FDA Class II recalls with potential for serious injury (such as sterility failure in ophthalmic products) are rated as Severe.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Neomycin Sulfate ophthalmic solution, 333 mg/mL. The recall covers all sizes of the prescription-only product manufactured and distributed between July 1, 2013, and October 19, 2013.
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 Neomycin Sulfate ophthalmic solution cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area. 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
- Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
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 (16)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 09242013@8
- 09242013@3
- 09242013@4
- 09242013@6
- 09242013@7
- 09242013@9
- 10012013@1
- 10012013@2
- 10012013@3
- 10012013@4
- 10012013@5
- 10012013@6
- 10032013@6
- 10142013@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 →Related recalls
Same manufacturer · Specialty Medicine Compounding Pharmacy
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