Recalls / Class II
Class IID-0356-2020
Product
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
- Affected lot / code info
- Lot #: RGA 7/19 7/31/2017; RGE 7/19 8/11/2017; RGG7/19 8/11/2017; RGH 7/19 8/17/2017; RHM 8/19 9/14/2017; RJB 10/19 10/23/2017; RJA 10/19 10/23/2017; SCA 3/20 3/22/2018; SIC 9/20 10/9/2018; TAP 1/21 2/26/2019; TDE 4/21 5/30/2019
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- 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
- 651528 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-0356-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.