Class II · Moderate risk
Travoprost Ophthalmic Solution
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Travoprost Ophthalmic Solution (Travoprost Ophthalmic Solution, 0.004%)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Affected NDC
0378-9651-32
Compare with the code on your package — it is the most precise check available.
Drug: Travoprost 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 |
|---|---|---|---|---|
| Travoprost Ophthalmic Solution, 0.004% NDC 00378-9651 |
TRAVOPROST .04 mg/mL | Solution/ Drops Ophthalmic |
Mylan Pharmaceuticals Inc. | Rx |
- Recalling firm
- Mylan Pharmaceuticals Inc
- NDC code
- 0378-9651-32
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0748-2022 · 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 Travoprost recalls
See all
Class II · Moderate risk
Travoprost Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Travoprost Ophthalmic Solution USP
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Other recalls by Mylan Pharmaceuticals Inc
All 2022 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.