Class II
Ongoing
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.
- Recall Initiated
- January 30, 2023
- Posted
- July 19, 2023
- Recall Number
- D-0922-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 400,008 bottles total for all products
- Firm Location
- Chennai, India
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
Product was distributed to two distributors who further distributed Nationwide in the USA.
Lot / Code Info
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
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