Minolira extended-release tablets recalled due to discontinued quality assurance program
EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.
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: This is an FDA Class II recall involving discontinuation of a manufacturer's quality assurance program, creating a risk-of-harm scenario. However, no hospitalization reports or documented injuries are mentioned in the source, so the severity does not meet the 'Severe' threshold (Score 4), which requires hospitalization reports.
Plain-English summary
EPI Health, LLC is recalling minolira (minocycline hydrochloride) extended-release tablets, 135 mg, 30-count bottles, due to a manufacturing deviation. The drug manufacturer, Dr Reddy's Laboratories Limited, discontinued its quality assurance program, which creates the potential that the product may not meet required standards for identity, strength, quality, and purity.
The recalled product includes lot numbers T2201700 and T2201701 with an expiration date of February 28, 2025. The recall affects 5,664 bottles distributed nationwide.
Consumers with this medication should consult their pharmacist or healthcare provider regarding the recall and what actions to take.
The recalled product
- Product
- minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
- Manufacturer
- EPI Health, LLC
- Category
- Drug
- Hazard
- manufacturing-deviation
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 (1)
- lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025
Distribution
Distributed nationwide across the United States.
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