D-0921-2023 Class I Ongoing
FDA drug recall D-0921-2023 was initiated by Global Pharma Healthcare Private Limited on Jan 30, 2023 and is designated Class I. Reason for recall: Non-Sterility: FDA analysis found unopened products to have bacterial contamination. The recall status is ongoing. Affected quantity: 400,008 bottles total for all products.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 19, 2023
- Initiation Date
- Jan 30, 2023
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0921-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026