Drug product
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.
D-0922-2023
Product summary
- Event
- Event 91621
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 400,008 bottles total for all products
- Official record key
drug-enforcement:D-0922-2023
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 #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
Distribution pattern: Product was distributed to two distributors who further distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations