D-0833-2018 Class III Terminated
FDA drug recall D-0833-2018 was initiated by Milbar Laboratories, Inc. on May 4, 2018 and is designated Class III. Reason for recall: Subpotent The recall status is terminated (terminated March 18, 2019). Affected quantity: 1,348 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- March 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,348 bottles
Product Description
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Reason for Recall
Subpotent
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.
Code Information
Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019