Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157
Summary
The FDA issued a Class II for Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackage by RemedyRepack Inc.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0378-2025
Action Date
2025-04-30
Status
Ongoing
Category
drug
Product Description
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
Lot/Code Info: Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
Quantity Affected: 1,858 30-count blister cards
Reason for Recall
CGMP Deviations
Distribution
PA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-24
Company
Indiana, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 56 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RemedyRepack Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RemedyRepack Inc. have FDA actions?
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0378-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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