Why it was recalled
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Product description
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-912-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 27, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Earthlabs, Inc. DBA Wise Woman Herbals
Original FDA data
Every field from FDA enforcement report D-912-2013, exactly as published.
Show all FDA fields
- City
- Creswell
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 65606
- Address
- 185 N Mill Street
- 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.
- Postal code
- 97426-9774
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-912-2013
- Classification
- Class II
- Recalling firm
- Earthlabs, Inc. DBA Wise Woman Herbals
- Product quantity
- 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
- Termination date
- Nov 21, 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
- Distribution pattern
- Nationwide
- Recall initiation date
- May 27, 2013
- Initial firm notification
- Telephone
- Center classification date
- Aug 20, 2013