Drug product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
D-0921-2023
Product summary
- Event
- Event 91621
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 400,008 bottles total for all products
- Official record key
drug-enforcement:D-0921-2023
Official wording
Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Code information: Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023
Distribution pattern: Product was distributed to two distributors who further distributed Nationwide in the USA.
Derived failure modes
-
Microbial contamination
bacterial contamination