Spironolactone Ophthalmic Solution 0 recalled over sterility concerns
- Recall date
- August 18, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Prescription Labs Inc dba Greenpark recalls Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
- Recall number
- D-0804-2021
- FDA classification
- Class II
- Brand / firm
- Prescription Labs Inc dba Greenpark
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
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