FDA Drug Recalls

Recalls / Class II

Class IID-0483-2017

Product

MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28

Affected lot / code info
Lot #103811; Exp. 09/17 Lot #105304; Exp. 04/18 NDC 69020-205-28 UPC 857181005108

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
3,600 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-0483-2017. 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