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
Reported: November 27, 2019 Initiated: July 2, 2019 #D-0443-2020
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Altaire Pharmaceuticals, Inc.
- Units Affected
- 9518 units
- Distribution
- U.S.A. Nationwide
- Location
- Aquebogue, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 9518 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0443-2020.
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