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Class II · Moderate risk Terminated Initiated Jul 12, 2019 (7 years ago)

Stone Purger Capsules

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Recalling firm
Herbal Doctor Remedies
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1617-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Herbal Doctor Remedies

All 2019 recalls
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CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

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CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

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Other cgmp deviation recalls from 2019

All cgmp deviation recalls
Class II · Moderate risk

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cGMP violations

Terminated cGMP deviation Wisconsin Pharmacal Company, LLC NDC 68093-0730-1 D-0781-2020