D-0088-2021 Class II Terminated

Recalled by Milbar Laboratories, Inc. — East Haven, CT

FDA drug recall D-0088-2021 was initiated by Milbar Laboratories, Inc. on October 9, 2020 and is designated Class II. Reason for recall: GMP Deviations The recall status is terminated (terminated January 4, 2023). Affected quantity: 5,312 bottles.

Recall Details

Product Type
Drugs
Report Date
November 25, 2020
Initiation Date
October 9, 2020
Termination Date
January 4, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,312 bottles

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

Reason for Recall

GMP Deviations

Distribution Pattern

Product was distributed throughout the United States, including Puerto Rico and internationally.

Code Information

Lot #: GW905-5, Exp. Date Jul-22 Lot #: KV428-3, Exp. Date Oct-21