OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05
Reported: November 27, 2019 Initiated: July 2, 2019 #D-0444-2020
Product Description
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Altaire Pharmaceuticals, Inc.
- Units Affected
- 103856 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, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 103856 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-0444-2020.
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