Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
Where it was sold
Product was distributed to two distributors who further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0922-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 30, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 400,008 bottles total for all products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Pharma Healthcare Private Limited
Original FDA data
Every field from FDA enforcement report D-0922-2023, exactly as published.
Show all FDA fields
- City
- Chennai
- Status
- Ongoing
- Country
- India
- Event ID
- 91621
- Address
- A - 9 Sidco Pharmaceutical Complex
- Address (line 2)
- Thiruporur
- Code information
- Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0922-2023
- Classification
- Class II
- Recalling firm
- Global Pharma Healthcare Private Limited
- Product quantity
- 400,008 bottles total for all products
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Recall initiation date
- Jan 30, 2023
- Initial firm notification
- Center classification date
- Jul 14, 2023