FDA Issues Class II Recall of Clindamycin Capsules Due to Manufacturing Deviations
RemedyRepack Inc. is voluntarily recalling 1,858 bottles of Clindamycin HCl 300 mg capsules due to Current Good Manufacturing Practice deviations. The product was distributed in Pennsylvania.
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 for manufacturing process deviations with no reported illnesses or injuries. The voluntary nature and absence of reported harm classify this as a Moderate severity precautionary recall.
Plain-English summary
RemedyRepack Inc. is voluntarily recalling Clindamycin HCl 300 mg capsules (NDC 70518-3772-00) due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 1,858 bottles of 30-count blister cards that were distributed in Pennsylvania.
CGMP deviations indicate potential issues with how the medication was manufactured, packaged, or quality-controlled. These manufacturing process defects could affect the medication's quality, but no illnesses or injuries have been reported in connection with this product.
The affected product was distributed in Pennsylvania. Patients and healthcare providers who possess bottles from the affected lots should verify whether they have the recalled medication.
Patients should contact their healthcare provider or pharmacy to determine if they have the affected product. The affected lot numbers are J0826722-121624 (expires 12/31/2025), J0820365-111324 (expires 11/30/2025), and J0814691-101624 (expires 10/31/2025). Additional information is available from the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antibiotic
- Hazard
- cgmp-deviation
- manufacturing-defect
Distribution
Distributed in 1 state:
- PA
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