Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Reported: April 13, 2022 Initiated: April 1, 2022 #D-0748-2022
Product Description
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Reason for Recall
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc
- Units Affected
- 20,112 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Morgantown, WV
Frequently Asked Questions
What product 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.. Recalled by Mylan Pharmaceuticals Inc. Units affected: 20,112 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0748-2022.
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