Why it was recalled
Lack of Assurance of Sterility
Product description
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01
Lot numbers, UPCs & expiration codes
17217 7/19 11/10/2017 18256 10/20 17236 8/31/2019 17334 11 /30/2019 18015 1/31/2020
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-0443-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 2, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 9518 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Altaire Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0443-2020, 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
- 17217 7/19 11/10/2017 18256 10/20 17236 8/31/2019 17334 11 /30/2019 18015 1/31/2020
- Postal code
- 11931-0849
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0443-2020
- Classification
- Class II
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- Product quantity
- 9518 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01
- 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