Drug 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
D-0367-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 1537130 units
- Official record key
drug-enforcement:D-0367-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 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
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility