FDA Drug Recalls

Recalls / Class III

Class IIID-0832-2018

Product

T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Affected lot / code info
Lot # MT390-8, expiration date 12/01/2020 GU925-4, expiration date 07/05/2020

Why it was recalled

Subpotent

Recalling firm

Firm
Milbar Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
20 Commerce St, N/A, East Haven, Connecticut 06512-4145

Distribution

Quantity
952 bottles
Distribution pattern
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.

Timeline

Recall initiated
2018-05-04
FDA classified
2018-05-22
Posted by FDA
2018-05-30
Terminated
2019-03-18
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0832-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls