FDA Drug Recalls

Recalls / Class II

Class IID-0088-2021

Product

(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

Affected lot / code info
Lot #: GW905-5, Exp. Date Jul-22 Lot #: KV428-3, Exp. Date Oct-21

Why it was recalled

GMP Deviations

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
5,312 bottles
Distribution pattern
Product was distributed throughout the United States, including Puerto Rico and internationally.

Timeline

Recall initiated
2020-10-09
FDA classified
2020-11-17
Posted by FDA
2020-11-25
Terminated
2023-01-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0088-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.