Delsam Pharma's ARTIFICIAL TEARS recall: CGMP Deviations
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.
Why was Delsam Pharma's ARTIFICIAL TEARS 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- 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.
- Recalling firm
- Global Pharma Healthcare Private Limited
- Quantity
- 400,008 bottles total for all products
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Recall date
- July 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)