May 2013 FDA Recall Drug by Earthlabs, Inc. Dba Wise Woman Herbals
D-912-2013 - Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products

This Class II drug recall was voluntarily initiated by Earthlabs, Inc. Dba Wise Woman Herbals on May 27, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; lack of assurance of sterility; product not manufactured under sterile conditions as required for ophthalmic drug products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-912-2013

Reason for Recall
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Initiated
05-27-2013
Reported
08-28-2013
Quantity
581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65606
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.
Earthlabs, Inc. DBA Wise Woman Herbals
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-21-2013
Product Description About Product Description
Full technical description of the product.
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR

Batch or Lot Expiration Information

Lot# 10010 Best used by: 07/14/13
Lot# 10285 Best used by: 02/16/14
Lot# 10640 Best used by: 11/09/14
Lot# 11107 Best used by: 09/16/15
Lot# 11408 Best used by: 05/04/16
Lot# 11711 Best used by: 11/23/16
Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.