Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Clobetasol Propionate Topical Solution USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container; complaints of leakage.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
Affected NDC
33342-0321-86
Compare with the code on your package — it is the most precise check available.
Drug: Clobetasol
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 |
|---|---|---|---|---|
| Clobetasol Propionate NDC 33342-0321 |
.4625 mg/mL | Solution Topical |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Oxalis Labs
- NDC code
- 33342-321-86
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0492-2019 · 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 Clobetasol recalls
See all
Class II · Moderate risk
Clobetasol Propionate Shampoo
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Ointment
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Clobetasol propionate Cream USP
Subpotent Drug: Low assay result observed during long-term stability testing.
Other packaging defect recalls from 2019
All packaging defect recalls
Class III · Low risk
VCF Vaginal Contraceptive Foam
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class II · Moderate risk
Estradiol Vaginal Inserts USP
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
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