Drug product
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
D-912-2013
Product summary
- Event
- Event 65606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
- Official record key
drug-enforcement:D-912-2013
Official wording
Reason: Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Code 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.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility