Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations
Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths mentioned in the source. The hazard is a cGMP manufacturing deviation without a specified health risk. As a voluntary precautionary recall initiated by the firm with manufacturing process issues but no reported health effects, this meets the criteria for Moderate severity.
Plain-English summary
Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets packaged in 30-count bottles (National Drug Code 72189-0364-30, Lot 21JU2210 with expiration date July 31, 2023) distributed nationwide in the United States. Nine bottles of this medication were affected.
The recall was initiated due to cGMP (Good Manufacturing Practice) deviations identified during manufacturing. Direct Rx voluntarily initiated this recall on March 13, 2023, and the FDA classified it as a Class II recall.
Patients and healthcare providers who possess this medication should contact their healthcare provider or pharmacist for guidance. Consumers should not dispose of medications in household trash or wastewater; instead, follow local medication disposal instructions or contact their pharmacy.
The recalled product
- Product
- Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Manufacturer
- Direct Rx
- 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 (3)
- Lot
- expiry: 21JU2210
- exp 7/31/23
Distribution
Distributed nationwide across the United States.
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