Recalls / Class II
Class IID-0367-2020
Product
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50
- Affected lot / code info
- Lot #: SKG,Exp 08/21; SHK, Exp 08/21; SHJ, Exp 08/21; SEC, Exp 05/21; SCB, Exp 03/21; SBC, Exp 02/21; RLB, Exp 12/20; RBB, Exp 02/20; RHR, Exp 08/20; RFK, Exp 06/20; RAB, Exp 01/20; TAD, Exp 01/22; TAQ, Exp 01/22; TBI, Exp 02/22; TDB, Exp 04/22; QHE, Exp 08/19; QJD, Exp 10/19; SGE, Exp 07/21
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
- 1537130 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-0367-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.