Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Clonidine Hydrochloride Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
Affected NDC
29300-0137-01
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 hydrochloride NDC 29300-0137 |
.3 mg/1 | Tablet Oral |
Unichem Pharmaceuticals (USA), Inc. | Rx |
- Recalling firm
- Unichem Pharmaceuticals USA INC
- NDC code
- 29300-137-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1541-2022 · 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 II · Moderate risk
Ropivacaine HCl 123 mg
Lack of Assurance of Sterility
Other recalls by Unichem Pharmaceuticals USA INC
All 2022 recalls
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class II · Moderate risk
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I · High risk
Cyclobenzaprine Hydrochloride Tablets
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
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