Status
Ongoing
Drug Enforcement D-0922-2023
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.
Classification
Class II
Report Date
July 19, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 400,008 bottles total for all products
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Product was distributed to two distributors who further distributed Nationwide in the USA.
Location & Firm
- Recalling firm
- Global Pharma Healthcare Private Limited
- Address
-
A - 9 Sidco Pharmaceutical Complex, Thiruporur
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0922-2023
- Event ID
- 91621
- Recall initiation date
- January 30, 2023
- Center classification date
- July 14, 2023
- Code info
- Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- More code info
- —