Drug product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
D-0919-2023
Product summary
- Event
- Event 91621
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 400,008 bottles total for all products
- Official record key
drug-enforcement:D-0919-2023
Official wording
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Code information: Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025
Distribution pattern: Product was distributed to two distributors who further distributed Nationwide in the USA.
Derived failure modes
-
Microbial contamination
bacterial contamination