Recalls / Class II
Class IID-0418-2020
Product
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50
- Brand name
- Altalube
- Generic name
- Mineral Oil And Petrolatum
- Active ingredients
- Mineral Oil, Petrolatum
- Route
- Ophthalmic
- NDC
- 59390-198
- FDA application
- M018
- Affected lot / code info
- RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22
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
- 161077 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-0418-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.