Why it was recalled
Lack of Assurance of Sterility
Product description
OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
Lot numbers, UPCs & expiration codes
16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2
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-0448-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 2, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 296,314 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Altaire Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0448-2020, 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
- 16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2
- Postal code
- 11931-0849
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0448-2020
- Classification
- Class II
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- Product quantity
- 296,314 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
- 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