Ascend Recalls Minocycline Hydrochloride Tablets for Dissolution Failures
Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets due to low dissolution test results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries.
Plain-English summary
Ascend Laboratories LLC is recalling Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg, 30-count bottles. The recall involves 4,728 bottles distributed nationwide in the USA. The specific lot number is 19140414, with an expiration date of 12/2020.
The recall was initiated because the product failed dissolution specifications, specifically showing low out-of-specification results for dissolution testing. This means the tablets may not release the medication at the required rate.
Consumers with this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
- Brand
- MINOCYCLINE HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 4,728
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 #: 19140414
- Exp 12/2020
Distribution
Distributed nationwide across the United States.
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