FDA Drug Recalls

Recalls / Class II

Class IID-1194-2020

Product

Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Affected lot / code info
Lot: 45077 Discard by: 3/12/2020

Why it was recalled

Lack of Processing Control

Recalling firm

Firm
The Medicine Shoppe Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
3524b Tamiami Trl, Port Charlotte, Florida 33952-8100

Distribution

Quantity
1 tube
Distribution pattern
Florida

Timeline

Recall initiated
2020-04-06
FDA classified
2020-04-10
Posted by FDA
2020-04-22
Terminated
2022-12-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1194-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls