Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns
Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Leiter's Compounding is recalling Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection. The recall involves 76,315 total units distributed nationwide. The specific product is compounded in San Jose, CA, and is identified by NDC 70360-003-35.
The recall was initiated due to a lack of assurance of sterility. All compounded products within their expiration dates were produced using filters that are subject to a separate recall. The affected lots have expiration dates ranging from 09/21/2016 to 2/2/2017.
Healthcare providers and patients should stop using the affected Moxifloxacin intravitreal injections. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Ophthalmic
- Affected units
- 76,315
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 (2)
- All unexpired lots
- Expirations dates of 09/21/2016 to 2/2/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding 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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