D-0922-2023 Class II 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
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.
Distribution Pattern
Product was distributed to two distributors who further distributed Nationwide in the USA.
Code Information
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023