Lupin Pharmaceuticals Inc. 2022-06-22 Health serious FDA
Health · FDA · Recall #FDA-D-1150-2022
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for… Recall
Issued June 22, 2022 · Lupin Pharmaceuticals Inc.
In June 2022, Lupin Pharmaceuticals Inc. recalled the Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
What you should do
- 1 Stop using Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Lupin 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
- Lupin Pharmaceuticals Inc.
- Category
- Health
- Recall date
- June 22, 2022
- Units affected
- Not reported
- Sold at
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Recall number
- FDA-D-1150-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Lupin Pharmaceuticals Inc. has 19 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.