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Class II: temporary or reversible health riskOngoing

RemedyRePack Clindamycin HCl Capsule Recall

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: R…

RemedyRePack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
May 14, 2025
Recall ID
D-0411-2025
Check your lot numberHow we source this data

Summary

RemedyRePack recalled Clindamycin HCl Capsule starting Apr 22, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0411-2025 on May 14, 2025. Reason: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. Status: Ongoing.

Why it was recalled

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Product description

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

Lot numbers, UPCs & expiration codes

Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.

Where it was sold

Within U.S - PA, VA, FL.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0411-2025
Classification
Class II
Status
Ongoing
Recall initiated
Apr 22, 2025
FDA report date
May 14, 2025
Quantity
23 bottles/30 count- 690 capsules
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRePack Inc.

Original FDA data

Every field from FDA enforcement report D-0411-2025, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Ongoing
Country
United States
Event ID
96764
Address
625 Kolter Dr Ste 4
Code information
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Postal code
15701-3571
Report date
May 14, 2025
Product type
Drugs
Recall number
D-0411-2025
Classification
Class II
Recalling firm
RemedyRePack Inc.
Product quantity
23 bottles/30 count- 690 capsules
Reason for recall
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Distribution pattern
Within U.S - PA, VA, FL.
Recall initiation date
Apr 22, 2025
Initial firm notification
E-Mail
Center classification date
May 6, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0411-2025, published May 14, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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