Drug product
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
D-129-2013
Product summary
- Event
- Event 62237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 253 bottles
- Official record key
drug-enforcement:D-129-2013
Official wording
Reason: 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.
Code information: N/A
Distribution pattern: Product was distributed nationwide and Canada
Derived failure modes
-
Labeling or packaging
label does not state
-
Sterility assurance
Lack of Assurance of Sterility