Status
Terminated
Drug Enforcement D-129-2013
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Classification
Class II
Report Date
January 23, 2013
Termination Date
March 12, 2013
Product Information
- Product description
- I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
- Product quantity
- 253 bottles
- Reason for recall
- Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Product was distributed nationwide and Canada
Location & Firm
- Recalling firm
- James G. Cole, Inc.
- Address
-
1020 Wasco St Ste D and K, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-129-2013
- Event ID
- 62237
- Recall initiation date
- August 28, 2012
- Center classification date
- January 16, 2013
- Code info
- N/A
- More code info
- —