June 2017 FDA Recall Drug by Sigan Industries Inc.
D-0975-2017 - Microbial Contamination of Non Sterile Products; out of specification Total Plate Count

This Class II drug recall was voluntarily initiated by Sigan Industries Inc. on June 13, 2017 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile products; out of specification total plate count. The product was distributed in CA and the recall is currently terminated.

Recall Number: D-0975-2017

Reason for Recall
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Initiated
06-13-2017
Reported
07-19-2017
Quantity
19,608 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77591
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sigan Industries Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# lot number 17-01319, exp 01/19