Drug product
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.
D-0920-2023
Product summary
- Event
- Event 91621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 400,008 bottles total for all products
- Official record key
drug-enforcement:D-0920-2023
Official wording
Reason: 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.
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
Distribution pattern: Product was distributed to two distributors who further distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations