Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) (Brimonidine Tartrate, Timolol Maleate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
Affected NDC
0023-9211-05
Compare with the code on your package — it is the most precise check available.
Drug: Timolol Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Combigan brimonidine tartrate, timolol maleate NDC 00023-9211 |
BRIMONIDINE TARTRATE 2 mg/mL; TIMOLOL MALEATE 5 mg/mL | Solution/ Drops Ophthalmic |
Allergan, Inc. | Rx |
- Recalling firm
- Allergan Sales, LLC
- NDC code
- 0023-9211-05
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1056-2019 · 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 Allergan Sales, LLC
All 2019 recalls
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications
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