CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled
Leiter's Compounding is recalling Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection Total, distributed nationwide in the US. The recall was initiated on 20 Sep 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0016-2017
- FDA event ID
- 75230
- Recalling firm
- Leiter's Compounding, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2016
- FDA classified
- 12 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Sep 2016 | Recall initiated by company | |
| 12 Oct 2016 | Classified by FDA | +22 days |
| 19 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection Total recalled?
Yes. Leiter's Compounding recalled Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection Total on 20 Sep 2016. The recall is Class II and its status is Terminated. Recall number D-0016-2017.
Why was it recalled?
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Which lots are affected?
All unexpired lots; Expirations dates of 09/21/2016 to 2/2/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Leiter's Compounding
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|---|---|---|---|---|---|
| Drug | CLASS II | Mitomycin 02% 2 mg/mL) in Sterile Water for Injection recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine HCl 1% - Phenylephrine HCl 5% in Sterile Water recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin 10 mg/mL in 9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Brilliant Blue G 025% in 9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |