Class II · Moderate risk
Travoprost Ophthalmic Solution
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Travoprost Ophthalmic Solution USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
Drug: Travoprost Category: Eye Drops & Ophthalmic
- Recalling firm
- Par Pharmaceutical, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0154-2017 · 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 Travoprost recalls
See all
Class II · Moderate risk
Travoprost Ophthalmic Solution
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.
Class II · Moderate risk
Travoprost Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Par Pharmaceutical, Inc.
All 2016 recalls
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class III · Low risk
Frovatriptan Succinate Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
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