FDA Recall D-0031-2018
Lucky Mart Inc. · South El Monte, CA
Class I — life-threatening Terminated 427 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Recall record
- Recall number
D-0031-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2017-08-29
- Classified by FDA Center
- 2017-10-24
- FDA published
- 2017-11-01
- Terminated
- 2018-10-30
- Recalling firm
- Lucky Mart Inc.
- Firm location
- South El Monte, CA