Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: use of an unapproved raw material
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
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
Affected NDCs
0591-3510-04
0591-3510-54
Compare with the code on your package — it is the most precise check available.
Drug: Clonidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clonidine transdermal system Clonidine NDC 00591-3510 |
.3 mg/d | Patch Transdermal |
Actavis Pharma, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- NDC code
- 0591-3510-04
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0474-2026 · 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.
Other Clonidine recalls
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Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
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Class III · Low risk
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
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Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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