Clindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.
RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg, due to current Good Manufacturing Practice (CGMP) deviations—the products were manufactured in a shared facility with Ezetimibe tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: This is an FDA Class II recall. The source text does not report any illnesses or injuries, and the hazard is a manufacturing practice deviation in a shared facility without explicit evidence of contamination or direct harm. This meets the criterion for a Moderate severity recall.
Plain-English summary
RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg (NDC#: 70518-3772-02), distributed in the United States in Pennsylvania, Virginia, and Florida. The recall is issued due to current Good Manufacturing Practice (CGMP) deviations. The products were manufactured in a shared facility with Ezetimibe tablets.
The affected product is packaged as 30 capsules per bottle. Recall lot numbers are B3698036-033125 and B3688703-032625, with expiration dates of 07/31/2026. A total of 23 bottles containing 690 capsules is involved.
Patients taking this medication should consult their healthcare provider or pharmacist if they have questions about whether they received affected product. Healthcare providers and patients should report any adverse effects to the FDA MedWatch program.
The recalled product
- Product
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
- Manufacturer
- RemedyRePack Inc.
- Category
- Drug — Oral capsule / Antibiotic
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#: B3698036-033125
- B3688703-032625
- Exp.: 07/31/2026.
Distribution
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