Minocycline extended-release tablets failed dissolution testing during stability analysis
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification dissolution result with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, prescription only, manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, New Jersey, NDC 67877-644-30, are being recalled. The action covers 360 bottles.
The stated reason is failed dissolution specifications: an out-of-specification result was observed during the ninth month of dissolution test analysis. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
The affected lot is 25141635, expiring 4/30/2028. Distribution was nationwide in the USA.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
- Brand
- MINOCYCLINE HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Extended-release tablet
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 (2)
- Lot# 25141635
- Exp 4/30/2028
Distribution
Distributed nationwide across the United States.
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