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.
Reported: July 19, 2023 Initiated: January 30, 2023 #D-0922-2023
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
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Details
- Recalling Firm
- Global Pharma Healthcare Private Limited
- Units Affected
- 400,008 bottles total for all products
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Location
- Chennai, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 400,008 bottles total for all products.
Why was this product recalled? ▼
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0922-2023.
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