Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
PIYANPING Anti-Itch
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.
Affected NDC
68085-8012-04
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
- Recalling firm
- Lucky Mart Inc.
- NDC code
- 68085-8012-4
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0031-2018 · 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 Hydrocortisone recalls
See all
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other cgmp deviation recalls from 2017
All cgmp deviation recalls
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