Clindamycin HCl Capsules 300 mg Recalled Due to Manufacturing Practice Deviations
RemedyRePack Inc. is recalling Clindamycin HCl Capsule 300 mg due to manufacturing practice deviations in a facility shared with Ezetimibe tablets. Affected lots B3698036-033125 and B3688703-032625 were distributed in PA, VA, and FL.
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: FDA Class II recall without reported illnesses or injuries. The hazard is a Current Good Manufacturing Practice deviation in a shared facility, representing a theoretical risk to product quality rather than a confirmed contamination or reported harm.
Plain-English summary
RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg (NDC 70518-3772-02) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The product was manufactured in a facility that also produces Ezetimibe tablets.
The affected bottles contain 30 capsules each. Two lot numbers are involved: B3698036-033125 and B3688703-032625, with an expiration date of July 31, 2026. A total of 23 bottles (690 capsules) were distributed within the United States, specifically in Pennsylvania, Virginia, and Florida.
Clindamycin HCl is an antibiotic used to treat bacterial infections. The CGMP deviations raise the potential for product quality issues. Consumers who have this medication should consult their pharmacy or healthcare provider immediately.
Consumers should not use the affected units and should return them to their pharmacy or contact RemedyRePack Inc. for instructions on safe disposal or replacement.
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 — Prescription Antibiotic
- Hazard
- cgmp-deviation
- manufacturing-quality-defect
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
Distributed in 3 states:
- FL
- PA
- VA
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