D-0921-2023 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- January 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400,008 bottles total for all products
Product Description
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.
Reason for Recall
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Distribution Pattern
Product was distributed to two distributors who further distributed Nationwide in the USA.
Code Information
Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023