Why it was recalled
GMP Deviations
Product description
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
Lot numbers, UPCs & expiration codes
Lot #: GW905-5, Exp. Date Jul-22 Lot #: KV428-3, Exp. Date Oct-21
Where it was sold
Product was distributed throughout the United States, including Puerto Rico and internationally.
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-0088-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 5,312 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Milbar Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0088-2021, exactly as published.
Show all FDA fields
- City
- East Haven
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86579
- Address
- 20 Commerce St
- Code information
- Lot #: GW905-5, Exp. Date Jul-22 Lot #: KV428-3, Exp. Date Oct-21
- Postal code
- 06512-4145
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0088-2021
- Classification
- Class II
- Recalling firm
- Milbar Laboratories, Inc.
- Product quantity
- 5,312 bottles
- Termination date
- Jan 4, 2023
- Reason for recall
- GMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally.
- Recall initiation date
- Oct 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2020