Class II · Moderate risk
Ramipril Capsules USP 10 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Schwinnng Herbal Dietary Supplement Capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
- Recalling firm
- Stop Clopez Corp
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Apr 22, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0494-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other unapproved drug recalls from 2024
All unapproved drug recalls
Class II · Moderate risk
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
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