Recalls / Class II
Class IID-0461-2020
Product
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
- Brand name
- Diclofenac
- Generic name
- Diclofenac Sodium
- Active ingredient
- Diclofenac Sodium
- Route
- Ophthalmic
- NDC
- 59390-149
- FDA application
- ANDA203383
- Affected lot / code info
- 17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Altaire Pharmaceuticals, Inc.
- Manufacturer
- Altaire Pharmaceuticals Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 311 W Ln, PO Box 849, Aquebogue, New York 11931-0849
Distribution
- Quantity
- 49527 units
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-07-02
- FDA classified
- 2019-11-15
- Posted by FDA
- 2019-11-27
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.