OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
Reported: November 27, 2019 Initiated: July 2, 2019 #D-0440-2020
Product Description
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Altaire Pharmaceuticals, Inc.
- Units Affected
- 81403 units
- Distribution
- U.S.A. Nationwide
- Location
- Aquebogue, NY
Frequently Asked Questions
What product was recalled? ▼
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 81403 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-0440-2020.
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