Recalls / Class III
Class IIID-0833-2018
Product
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
- Affected lot / code info
- Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019
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
- 1,348 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-0833-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.