FDA Drug Recalls

Recalls / Class II

Class IID-0486-2017

Product

MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28

Affected lot / code info
Lot #103810; Exp. 09/17 Lot #105303; Exp. 04/18 NDC 69020-208-28 UPC 857181005092

Why it was recalled

CGMP Deviations

Recalling firm

Firm
Cherry Hill Sales Co.
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
1115 Eden Way N, N/A, Chesapeake, Virginia 23320-2751

Distribution

Quantity
2,400 cartons
Distribution pattern
Michigan, Illinois, New York, Florida, Pennsylvania .

Timeline

Recall initiated
2017-01-27
FDA classified
2017-02-18
Posted by FDA
2017-03-01
Terminated
2017-04-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0486-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.