Mylan Pharmaceuticals Inc 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-D-0748-2022
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for:… Recall
Issued April 13, 2022 · Mylan Pharmaceuticals Inc
In April 2022, Mylan Pharmaceuticals Inc recalled the Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Mylan Pharmaceuticals Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Mylan Pharmaceuticals Inc
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Puerto Rico
- Recall number
- FDA-D-0748-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Mylan Pharmaceuticals Inc has 4 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.