Zileuton Extended-Release Tablets recalled for failed dissolution specifications
Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Failed dissolution specifications represent a risk to drug efficacy. Per rubric, when no injuries are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Zileuton Extended-Release Tablets, 600 mg, 120-count bottles (NDC 68180-169-16) due to failed dissolution specifications. Out-of-specification test results were observed during dissolution testing in a long-term stability study, indicating the tablets may not dissolve properly.
The affected lots are M100070, M100239 (expiring 06/22), M100312 (expiring 09/22), and M100366 (expiring 10/22). Approximately 3,216 bottles were distributed to 10 wholesalers and distributors and one mail order account, with potential nationwide distribution.
Consumers who have received tablets from the affected lots should contact their healthcare provider or pharmacist. Do not stop taking your medication without consulting your healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- dissolution-failure
- efficacy-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots: M100070
- M100239
- Exp. 06/22
- M100312
- Exp.09/22
- M100366
- Exp.10/22
Distribution
Distributed nationwide across the United States.
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