FDAFDA · Food and drugs·Recall number D-0922-2023
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.
Published July 19, 2023 · Recall initiated: January 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Global Pharma Healthcare Private Limited
- Distributor
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Lot
- Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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