Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Timolol-Brimonidine-Dorzolamide-Latanoprost
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
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
Drug: Timolol Category: Eye Drops & Ophthalmic
- Recalling firm
- ImprimisRx CA, Inc., dba ImprimisRx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1133-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Timolol recalls
See all
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
Other recalls by ImprimisRx CA, Inc., dba ImprimisRx
All 2017 recalls
Class II · Moderate risk
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Curcumin Emulsion 10mg/ml Injection
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
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