Status
Ongoing
Drug Enforcement D-0921-2023
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Classification
Class I
Report Date
July 19, 2023
Termination Date
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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
- Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- 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-0921-2023
- Event ID
- 91621
- Recall initiation date
- January 30, 2023
- Center classification date
- July 14, 2023
- Code info
- Lot #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023
- More code info
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