Why it was recalled
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
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 #: PCMH001, PCMH002, PCMH005, PCMH007, 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-0921-2023
- Classification
- Class I
- 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-0921-2023, 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 #: PCMH001, PCMH002, PCMH005, PCMH007, Exp. date NOV-2023
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0921-2023
- Classification
- Class I
- Recalling firm
- Global Pharma Healthcare Private Limited
- Product quantity
- 400,008 bottles total for all products
- Reason for recall
- Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- 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