Timolol-Brimonidine-Dorzolamide-Latanoprost % Ophthalmic Drops recalled over undeclared excipient
- Recall date
- June 23, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ImprimisRx CA, Inc., dba ImprimisRx recalls Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a…
- Recall number
- D-1133-2017
- FDA classification
- Class II
- Brand / firm
- ImprimisRx CA, Inc., dba ImprimisRx
- Sold / distributed
- Nationwide
Why it was recalled
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
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