Recalls / Class II
Class IID-0478-2020
Product
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05
- Brand name
- Ciprofloxacin Hcl Ophthalmic
- Generic name
- Ciprofloxacin Hydrochloride
- Active ingredient
- Ciprofloxacin Hydrochloride
- Route
- Ophthalmic
- NDC
- 59390-217
- FDA application
- ANDA204613
- Affected lot / code info
- Lot #: 18164, Exp 7/20
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
- 6024 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-0478-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.