Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Affected NDC
0591-3508-04
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 00591-3508 |
.1 mg/d | Patch Transdermal |
Actavis Pharma, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0591-3508-04
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0235-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clonidine recalls
See all
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class III · Low risk
Clonidine Hydrochloride Tablets
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Other recalls by Teva Pharmaceuticals USA
All 2021 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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