Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Reported: June 22, 2022 Initiated: June 10, 2022 #D-1150-2022
Product Description
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Reason for Recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 3,216 bottles
- Distribution
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 3,216 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2022. Severity: Moderate. Recall number: D-1150-2022.
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