D-0975-2017 Class II Terminated

Recalled by Sigan Industries Inc. — Brampton

FDA drug recall D-0975-2017 was initiated by Sigan Industries Inc. on June 13, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non Sterile Products; out of specification Total Plate Count The recall status is terminated (terminated March 15, 2019). Affected quantity: 19,608 tubes.

Recall Details

Product Type
Drugs
Report Date
July 19, 2017
Initiation Date
June 13, 2017
Termination Date
March 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,608 tubes

Product Description

CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033

Reason for Recall

Microbial Contamination of Non Sterile Products; out of specification Total Plate Count

Distribution Pattern

CA

Code Information

lot number 17-01319, exp 01/19