D-0920-2023 Class II Ongoing
FDA drug recall D-0920-2023 was initiated by Global Pharma Healthcare Private Limited on Jan 30, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 400,008 bottles total for all products.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 19, 2023
- Initiation Date
- Jan 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400,008 bottles total for all products
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.
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 #: PCMH009, PCMH010, PCMH011, PCMH012, PCMH013, PCMH014, PCMH015, PCMH016, exp. date Nov-2023; PCMI001, PCMI002, PCMI003, PCMI004, PCMI006, PCMI 07, PCMI 008, Exp. date AUG-2024; PCMJ003, PCMJ007, PCMJ016, Exp. date MAR-2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0920-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026