Why it was recalled
Subpotent
Product description
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Lot numbers, UPCs & expiration codes
Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019
Where it was sold
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0833-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 4, 2018
- FDA report date
- May 30, 2018
- Quantity
- 1,348 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Milbar Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0833-2018, exactly as published.
Show all FDA fields
- City
- East Haven
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 80045
- Address
- 20 Commerce St
- Code information
- Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019
- Postal code
- 06512-4145
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0833-2018
- Classification
- Class III
- Recalling firm
- Milbar Laboratories, Inc.
- Product quantity
- 1,348 bottles
- Termination date
- Mar 18, 2019
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
- 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.
- Recall initiation date
- May 4, 2018
- Initial firm notification
- Letter
- Center classification date
- May 22, 2018