Why it was recalled
Lack of Assurance of Sterility
Product description
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
Lot numbers, UPCs & expiration codes
17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23
Where it was sold
U.S.A. Nationwide
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-0450-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 2, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 81217 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Altaire Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0450-2020, exactly as published.
Show all FDA fields
- City
- Aquebogue
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 83265
- Address
- 311 W Ln
- Address (line 2)
- PO Box 849
- Code information
- 17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23
- Postal code
- 11931-0849
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0450-2020
- Classification
- Class II
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- Product quantity
- 81217 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jul 2, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 15, 2019