Status
Ongoing
Drug Enforcement D-0919-2023
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
- Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
- 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-0919-2023
- Event ID
- 91621
- Recall initiation date
- January 30, 2023
- Center classification date
- July 14, 2023
- Code info
- Lot #: PCMI005, Exp. date AUG-2024; PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, PCMJ015, Exp. date MAR-2025
- More code info
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