FDA Drug Recalls

Recalls / Class II

Class IID-0089-2021

Product

(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Affected lot / code info
Lot #: MV678, Exp. Date Dec-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
2,664 tubes
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-0089-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.