Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD…
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Read the official notice →- Date
- 2022-06-22
- Country
- United States
- Brand
- Lupin Pharmaceuticals
- Product
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by…
- Classification
- Class II
- Units
- Product was distributed to 10 wholesalers/distributors and one mail order…
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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US